10 Best Fda Approved Blood Pressure Monitor of 2025

Tested and Reviewed: Top 10 Fda Approved Blood Pressure Monitor deals with expert ratings from 8.1 to a perfect 10

September 2025 Edition

Editor's Choice

9.7

OMRON

OMRON Platinum Blood Pressure Monitor, Upper Arm Cuff, Digital Bluetooth Blood Pressure Machine, Stores Up To 200 Readings for Two Users (100 readings each)

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Editor's bottom line:

“This fda approved blood pressure monitor is the best one we tested. In terms of quality, brand and price, we couldn't ask for more.”

Main Highlights

The OMRON Platinum Upper Arm Monitor, complete with D-Ring cuff, provides unlimited memory, stores 200 total blood pressure readings for 2 users, works with the free OMRON Connect app
No.1 doctor and pharmacist recommended brand of blood pressure monitors.
The high morning average indicator alerts the user if systolic or diastolic measurements are out of normal range in the morning, when there is a higher risk for heart attack or stroke. This feature is unique to the Gold and Platinum series monitors.
The OMRON Platinum monitor is the only monitor to feature a high-contrast black, backlit dual-display LCD screen that allows the user to immediately compare their current reading to their previous reading.
Backed with a 6-year warranty. OMRON stands behind the accuracy and quality of our products, and believes in the longevity of our blood pressure monitors. Registered with the FDA as a medical device
The convenient AC adapter helps make sure your monitor is ready whenever you are and eliminates the worry of changing the batteries in your OMRON Blood Pressure Monitor. Also comes with a handy storage case.
This product meets the Validated Device Listing (VDL) criteria for validation of clinical accuracy, based on the independent review and acceptance of documentation submitted by the manufacturer.

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Picked by 337 people today

9.5

Omron

OMRON Gold Blood Pressure Monitor, Premium Upper Arm Cuff, Digital Bluetooth Blood Pressure Machine, Clinically Validated, FDA Cleared, FSA/HSA Eligible

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Main Highlights

The OMRON Gold Upper Arm Monitor provides unlimited memory and stores 120 total blood pressure readings for 2 users. The OMRON Gold Upper Arm Monitor also works with the OMRON Connect free app.
Doctor and pharmacist recommended brand of blood pressure monitors.
The Gold cuff fits all large and standard adult upper arms 9 to 17 in circumference. This soft, wide-range D-ring cuff is designed for a more comfortable measurement.
The high morning average indicator alerts the user if systolic or diastolic measurements are out of normal range in the morning, when there is a higher risk for heart attack or stroke. This feature is unique to the Gold and Platinum series monitors.
The OMRON Gold monitor features a dual-display, last reading comparison, and easy screen navigation. For added convenience, a handy storage case is included.
Backed with a 5-year warranty. OMRON stands behind the accuracy and quality of our products, and believes in the longevity of our blood pressure monitors. Registered with the FDA as a medical device.
OMRON, the #1 doctor and pharmacist-recommended brand of blood pressure monitors in the U.S., has a 50-year history of providing accurate, reliable products, and is the world's best selling blood pressure monitor brand.
This product is FDA-registered as a medical device, has a five-year warranty, and is FSA/HSA-eligible. This monitor meets the Validated Device Listing (VDL) criteria for Clinical Accuracy as determined through an independent review process.

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9.5

Invaxe

Blood Pressure Machine, Automatic Upper Arm Blood Pressure Monitor with 2x199 readout, 4.5 inch Backlit Large Screen Adjustable Large Cuff 9 to 17 inches - arrhythmia and Home Hypertension Detector

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Main Highlights

Large Cuff: The large cuff ensures a comfortable fit for most adult users, providing accurate and reliable readings
Battery Powered: Convenient and portable, this blood pressure monitor operates on batteries, allowing you to use it anywhere, anytime
Automatic Operation: Easy to use with just one touch, this monitor automatically inflates the cuff and provides quick, precise readings

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Best Value

9.2

Save 40%

Omron

OMRON Evolv Bluetooth Wireless Upper Arm Blood Pressure Monitor with Portable, One-Piece Design, FDA Cleared, Clinically Validated, FSA/HSA Eligible, Machine, Cuff

40% OffFree Shipping

Main Highlights

OMRON Evolv is our most portable upper arm monitor ever; Its compact, 1-piece design features simple, intuitive controls that make it easy to set up and use.
With advanced accuracy, our exclusive heart health algorithm, this innovative, upper arm 1-piece blood pressure monitor measures more data points and eliminates interference from movement for more precise, clinically accurate readings.
Works with the free OMRON app that allows for unlimited users/readings and sharing results with family or healthcare providers.
OMRON, the #1 doctor and pharmacist-recommended brand of blood pressure monitors in the U.S., has a 50-year history of providing accurate, reliable products, and is the world's best selling blood pressure monitor brand.
This product is FDA-registered as a medical device, has a five-year warranty, and is FSA/HSA-eligible. This monitor meets the Validated Device Listing (VDL) criteria for Clinical Accuracy as determined through an independent review process.

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9.0

Omron

OMRON Silver Upper Arm Blood Pressure Monitor with Large Display, Clinically Validated, Medical Grade, FDA Cleared, FSA/HSA Eligible, Uses OMRON Connect App for Unlimited Free Measurements

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Main Highlights

Easy-to-Read Display and Symbols The OMRON Silver upper arm blood pressure monitor features a large LCD screen with helpful symbols and simple descriptions, making it easy to read and understand your results.
Advanced Accuracy Technology This OMRON-exclusive technology measures five times more data points than previous OMRON models, minimizing the impact of body movement during measurements for more consistent and precise blood pressure readings.
Irregular Heartbeat Detection Receive an alert if up to 3 irregular heartbeats are detected during your measurement.
Wireless Bluetooth Convenience - Sync to the free OMRON connect app to store unlimited readings, track trends, and share your health data with your doctor.
Simple Storage and Cuff Design Includes a convenient storage case and a pre-formed, Easy-Wrap ComFit cuff that inflates 360 degrees around your arm to help reduce measurement errors. Fits adult upper arms 9 to 17 in circumference.

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8.8

Save 8%

Omron

OMRON Bronze Upper Arm Blood Pressure Monitor, Clinically Validated, Medical Grade, FDA Cleared, FSA/HSA Eligible, Uses OMRON Connect App for Unlimited Free Measurements

8% OffFree Shipping

Main Highlights

Simplified Design for 1 User - The OMRON Bronze upper arm blood pressure monitor is designed for one user, stores up to 14 blood pressure readings, and features a simple display with one-touch operation for quick and easy measurements.
Hypertension Indicator Alerts you if your systolic (upper) measurement reaches 130 mmHg or above, and/or if your diastolic (lower) measurement reaches 80 mmHg or above.
Irregular Heartbeat and Movement Detection Receive an alert when your heart beats irregularly and when body movements are detected during your measurement.
Wireless Bluetooth Convenience - Sync to the free OMRON connect app to store unlimited readings, track trends, and share your health data with your doctor.
Simple Storage and Cuff Design Includes a convenient storage case and a soft, wide-range D-ring cuff, featuring a contoured design for a more comfortable fit and measurement. Fits adult upper arms 9 to 17 in circumference.

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8.6

Save 20%

iHealth

iHealth Track Smart Upper Arm Blood Pressure Monitor with Wide Range Cuff That fits Standard to Large Adult Arms, Bluetooth Compatible for iOS & Android Devices

20% OffFree Shipping

Main Highlights

Clinically Accurate: Easy Operation by two buttons, Advanced Accuracy, No Calibration required.
Large Multi-Color Backlit Display: The large, oversized numbers make reading the results from this upper arm blood pressure monitoring device a breeze. Coded (GREEN/YELLOW/RED) display tells if your blood pressure readings are optimal or not.
Easy Management: Manage and track up to 99 readings on your blood pressure monitor and unlimited readings on your smartphone with iHealth's free iOS and Android applications ( iOS 12.0 or later. Android 9.0 or later.Requires Bluetooth 4.0.and up).
Heart Rhythm Disturbances: This unit automatically identifies and alerts you to any heart rhythm disturbances. If detected, a warning symbol will be displayed after the measurement is taken.
What You Get: 1 x blood pressure monitor that meets ESH 2010 performance standards, 4 AAA batteries, 1 wide range cuff that fits upper arms with Circumference of 8.7"-16.5" (22-42cm),1 Instruction manual, our worry-free 12-month warranty and friendly California-based customer service.
Please carefully read the instructions manual before first use to ensure measurement accuracy.Please contact our friendly customer support team if you have any concerns about the device.

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8.3

Omron

OMRON Iron Upper Arm Blood Pressure Monitor, Clinically Validated, Medical Grade, FDA Cleared, FSA/HSA Eligible, with Wide Range 17 Inch Cuff

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Main Highlights

Simplified Design for 1 User - The OMRON Iron upper arm blood pressure monitor is designed for one user, stores your last reading, and features a simple display with one-touch operation for quick and easy measurements. 4 AA batteries required (batteries not included).
Irregular Heartbeat Detection Receive an alert when your heart beats irregularly, which is vital information to track and share with your doctor.
Body Movement Detection Receive an alert if body movements are detected during your measurement.
Comfortable Cuff Design Includes a soft, wide-range D-ring cuff, featuring a contoured design for a more comfortable fit and measurement. Fits adult upper arms 9 to 17 in circumference.
OMRON, the #1 doctor and pharmacist-recommended brand of blood pressure monitors in the U.S., has a 50-year history of providing accurate, reliable products, and is the world's best selling blood pressure monitor brand.

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8.1

Save 28%

Oklar

Oklar Blood Pressure Monitors for Home Use Rechargeable Wrist Digital BP Machine Cuff with LED Backlit Display, Voice Broadcast, 240 Memory Storage for 2 Users with Carrying Case

28% OffFree Shipping

Main Highlights

Convenient Dual User Mode: Store up to 240 readings for two users, allowing easy tracking and comparison of measurements
Fast and Accurate Measurements: Our fully automatic wrist blood pressure machine provides fast and precise results, simply press the "START/STOP" button, and the measurement process takes 35 seconds; the device automatically turns off after 60 seconds of inactivity
Voice Broadcast Design: Our automatic blood pressure cuff features a voice broadcast function, making it ideal for individuals with poor eyesight; you can adjust the volume or turn off the sound using the SET and MEM buttons
Large LED Backlit Display: The large LED screen of our blood pressure monitor features clear numbers, ensuring easy readability even in low-light conditions, enjoy a hassle-free visual experience
Portable Rechargeable Blood Pressure Monitor: Equipped with a built-in rechargeable battery and Type-C cable for convenient charging anytime, eliminating the need for battery replacements and ensuring you can easily monitor your health (Note: Charging adapter not included in the packaging)
Adjustable Wrist Cuff: With an adjustable cuff ranging from 4.92 to 8.46 inches, it provides a more comfortable fit and ensures accurate measurements

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8.1

Save 17%

AILE

Blood Pressure Monitor,AILE blood pressure machine Upper Arm Large Cuff(8.7"-16.5"Adjustable),automatic high blood pressure cuff for home use,(BP)blood pressure monitor,2*99 memory,Easy to use/travel

17% OffFree Shipping

Main Highlights

[Accurate and Fast Blood Pressure machine] Each AILE blood pressure machine is individually calibrated, using Dutch high-precision chips and state-of-the-art algorithms to ensure unparalleled accuracy for every device. AILE blood pressure monitors provide reliable diastolic and systolic pressures, as well as heart rate in just 30 seconds. Measurement error: Blood pressure within 3 mmHg, pulse within 5%. Accurate and fast, you deserve to have it!
[Easy-to-Use and Read Blood Pressure machine] The AILE blood pressure monitor features a simple design - just put on the cuff, press the start button, and it works automatically, making it easy and fast to use. With a large LED electronic screen, bold fonts, and a screen angle designed for optimal viewing, it offers a very comfortable reading experience. AILE blood pressure machine is accessible for elderly people to use and read without any obstacles.
[Large Pressure Cuff for Universal Use] The AILE blood pressure machine comes with an adjustable large cuff, suitable for upper arm sizes ranging from 8.7 to 16.5. The strong Velcro around the pressure cuff allows for easy adjustments and prevents slipping during measurements. The blood pressure cuff is made of high-quality dust-resistant material, finely crafted, comfortable on the skin, and easy to clean. The AILE blood pressure machine ensures your health is well taken care of!
[Memory Function Blood Pressure Machine] The AILE blood pressure machine can automatically store 99 measurement values for 2 users (total of 198 readings), each with a timestamp, allowing you to review historical data and track changes in blood pressure and heart rate. One blood pressure monitor can be used by two individuals at the same time! The AILE blood pressure monitor is a great choice for families!
[High-Value Blood Pressure Machine] The AILE blood pressure monitor is developed and sold from our own factory, offering maximum cost savings. We also build the high quality! Our chief engineering designer is from the United States; Chips are sourced from advanced Dutch technology; the casing is made of high-density ABS material, durable, elegant, and aesthetically pleasing!
[Portable Travel Blood Pressure Monitor for home use] The AILE blood pressure monitor is compact and lightweight, suitable for use at home, in the office, or while traveling. It is Climate neutral certified by ClimatePartner, making it more energy-efficient. The BP monitor kit includes: 1 blood pressure machine, 1*large cuff, 1*blood pressure indicator card, 1*instruction manual, 1*USB cable (powered by 4*AAA batteries, batteries and adapter not included). 24-hour customer service available!

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Our Best Overall Choice

Best Choice

9.7

OMRON

OMRON Platinum Blood Pressure Monitor, Upper Arm Cuff, Digital Bluetooth Blood Pressure Machine, Stores Up To 200 Readings for Two Users (100 readings each)

Free Shipping

Editor's bottom line:

“This is the best one we tested. In terms of quality, brand and price, we couldn't ask for more.”

Main Highlights

The OMRON Platinum Upper Arm Monitor, complete with D-Ring cuff, provides unlimited memory, stores 200 total blood pressure readings for 2 users, works with the free OMRON Connect app
No.1 doctor and pharmacist recommended brand of blood pressure monitors.
The high morning average indicator alerts the user if systolic or diastolic measurements are out of normal range in the morning, when there is a higher risk for heart attack or stroke. This feature is unique to the Gold and Platinum series monitors.
The OMRON Platinum monitor is the only monitor to feature a high-contrast black, backlit dual-display LCD screen that allows the user to immediately compare their current reading to their previous reading.
Backed with a 6-year warranty. OMRON stands behind the accuracy and quality of our products, and believes in the longevity of our blood pressure monitors. Registered with the FDA as a medical device
The convenient AC adapter helps make sure your monitor is ready whenever you are and eliminates the worry of changing the batteries in your OMRON Blood Pressure Monitor. Also comes with a handy storage case.
This product meets the Validated Device Listing (VDL) criteria for validation of clinical accuracy, based on the independent review and acceptance of documentation submitted by the manufacturer.

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