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Top 7 FDA Approved Pulse Oximeter [2022]

FDA Approved Pulse Oximeters

While pulse oximeters became more apparent during the COVID-19 pandemic, this handheld device has always been popular in the medical, aviation, and sports community. Patients use them to track their asthma, chronic obstructive pulmonary diseases, and other lung conditions. Besides hospital and medical facilities, now pulse oximeters have been a staple in a regular households. One can simply put their finger in the device to check their blood oxygen level, pulse rate, etc. They are also used by pilots or endurance athletes who work or train at high altitudes.

What are Pulse Oximeters?

A pulse oximeter is an electronic device usually attached to a person’s fingers, wrist, ears, toes, foot, or nose to measure the level of oxygen in their red blood cells. The device offers instant results without the users giving a blood sample. It helps doctors determine whether a person requires supplement oxygen, ventilators support, or any airway pressure machine.

There are two types of pulse oximeters available in the market- Prescription pulse oximeters and OTC pulse oximeters. 

The prescription pulse oximeters are FDA-approved devices that receive 501(K) clearance due to their accuracy and reliability. Meanwhile, the FDA has not reviewed an over-the-counter (OTC) pulse oximeter. One can buy them from a drugstore. Although they offer accurate results, unlike their FDA-approved counterparts, one cannot trust the results entirely.

In this article, we have selected the top 7 FDA-approved pulse oximeters of 2022 based on their accuracy, type, technical features, and price.

Top 7 FDA Approved Pulse Oximeters [2022]

CMI Health PC-66H

CMI Health Battery Operated Pulse Oximeter
Image Source: Amazon.com

The CMI Health PC-66H is an FDA-approved handheld pulse oximeter to monitor spo2, pulse rate, and perfusion index. It measures your data rapidly, providing accurate health information and enabling you to make quick decisions in real-time. This medical-grade oximeter comes integrated with infant, pediatric, and adult sensors, allowing you to monitor or spot-check vitals across all ages continuously. This makes it suitable for both at-home and professional medical settings as well.

The device is manufactured according to CE, ISO 9001, and ISO 13485 standards providing pulse rate accuracy to 2 BMP and spo2 accuracy to 3 between 70-100 saturation levels. It comes with a durable HD, easy-to-read display to track Spo2, PR, and Plethysmogram just at a button click.

The device offers the highest battery backup, up to 384 hours of continuous oximetry data storage by recording data once every 1,2,4, and 8 seconds. You can send the data to your smartphone or PC for further review and analysis.


  • 384 hours of oximetry data storage
  • Record data every 1 second
  • Suitable for pediatric and infants
  • Support spot-checking and continuous monitoring


  • Heavy and a bit technical

Wellue Checkme O2 Max

Some days you wake up refreshed, while on other days, you wake up feeling like a bullet lodged in your head. The sleep tracker feature of the Checkme 02 monitors your sleep patterns and physical signs like heart rate and body movement. The device gives you a clear picture of how much quality sleep you are receiving, and you can use this information to optimize your sleep experience.

Wellue Checkme O2 Max is a high-end oximeter that monitors your spo2, heart rate, and body motion for up to 72 hours. It tracks your blood oxygen saturation and reveals whether you are suffering from any breathing disturbances and how long you spend in each stage of sleep (light, deep, and REM). If your blood 02 saturation or heart rate falls below a definite level, the device will trigger an audio and vibration alert to wake you up gently.

You can connect the device with your phone to receive intuitive health insights and save or share history data at no additional cost.


  • Support integration with apple health
  • 72 hours of continuous operation
  • Support sleep pattern tracking
  • Automatic audio and vibration alert
  • Built-in-memory


  • Expensive
  • A bit bulky

EMAY Sleep02 Pro

EMAY Bluetooth Oxygen is a medical-grade oximeter for continuously tracking blood oxygen saturation level and pulse rate. Unlike most Bluetooth devices where oxygen is recorded every 10-second intervals, the EMAY Sleep02 Pro records oxygen levels every second, offering exceptional relatability. Once the recording is finished, you can use the intelligent app to transfer the data to your pc or smartphone or print them out.

The device gives an impeccable runtime providing a professional and comprehensive trend report of 40 hours of data, allowing you to record 8 hours of data per night for five nights at a single charge. The screen will automatically go to sleep while the device is running in the background so that you don’t get distracted from the screen.

It comes with a durable body with a soft silicone clamp that is set perfectly on your finger and never slips the whole time. The additional soft-touch tube is designed to minimize discomfort and provide more accurate spo2 tracking, flow tracking, ODI analysis, and AHI analysis.


  • Record spo2 and pulse rate every second
  • Soft silicone clamp and nasal tubes
  • Massive data storage up to 8 GB
  • Large easy-to-read display


  • The app is too technical

Wellue PC-60FW Bluetooth Oximeter

Wellue PC-60FW Bluetooth Oximeter is an affordable oximeter that provides reading for 02 level, pulse strength, and pulse rate with super efficiency. The wellue PC-60FW oximeter comes with a durable body with a strong clamp and a hypoallergenic silicone cushion that perfectly holds your finger in position without giving you that pinching feeling.

You can also set an audio or visual alert so that the device will beep automatically when the 02 levels or pulse rate value exceeds the preset limit. Moreover, you can customize the abnormal value reminder range, measurement mode, and turn on/off the beep sound.

With its integrated Bluetooth chip, you can connect the device with your android or iOS phone and receive a real-time feed. The oximeter synchronizes the data in your phone, allowing you to read them at a later time. You can store the data in up to 12 groups to understand how your body reacts in different circumstances. For instance, you can compare your 02 and pulse rate while working out with while sitting idle.


  • Read and store data on smartphone
  • Affordable
  • Comfortable hold
  • Accurate reading


  • Not recommended for medical purposes (sports & aviation only)

Wellue O2Ring Oximeter

The Wellue O2Ring Oximeter is an FDA-certified device for tracking patients’ oxygen and heart rate with severe sleep apnea, COPD, and Atrial Fibrillation. It comes with a built-in rechargeable battery that delivers 12-16 hours of battery life in one single charge. It also has a built-in memory, meaning you can use it as a standalone device.

You can connect the device with Bluetooth and track the results on your smartphone using the wellue app. The app also displays overnight O2 reports, PR reports, and data trends that you can store and share in pdf and csv files. The oximeter automatically turns on when you wear it giving a live feed of your blood oxygen, heart rate, and body movements continuously through day and night. It comes with a patented soft silicon sensor ring providing accurate and faster reading compared to other products in the same price range.


  • Patented soft silicon sensor ring
  • Long-lasting battery
  • Device stores four sessions *10 hours of data
  • Support Windows & Mac 


  • The ring is slightly bulky

Santamedical oximeter

Spending more money does not always guarantee more value, and the Santamedical oximeter proves it correct. As the cheapest pulse oximeter on the market, the device shows accurate, reliable, and quick readings, clinically tested and proven. You can get your readings for blood spo2, pulse rate, and pulse strength within 8 seconds displayed on a large LED oximeter display.

The device is designed with latex-free silicone material that perfectly fits all sizes. Plus, its self-adjusted finger clamp does make your finger sweaty, giving accurate results continuously. It comes with 2 AAA batteries offering 30+ hours of continuous monitoring, which you rarely find even at high-end devices. Besides its low battery indicator, the device automatically shuts off after pulling it out of the finger, making it handier for sports and recreational use.

It comprises a lightweight body with an easy-to-read LED display that allows you in any environment- from bright sunlight to pitch dark.


  • Latex-free finger chamber
  • Hypoallergenic medical-grade silicon
  • Accurate reading within 8 seconds
  • 30+ hours of continuous monitoring
  • Affordable price


  • Not for medical use
  • No smartphone connect support

HealthTree Bluetooth Pulse Oximeter

The HealthTree Bluetooth Pulse Oximeter is another budget addition offering an accurate measure of blood oxygen saturation level, pulse rate, pulse strength, and waveform at a very affordable price. You can download the Healthtree app on your android or iOS and monitor your vitals through your phone.

The device continuously records and stores reading for up to 10 hours and generates real-time data, graphic reports, and trends in blood oxygen saturation and heart rate. The device automatically turns off within 10 seconds after removing it from the finger, making it more energy-efficient.

The Healthtree app stores your health information, allowing you to review your history data via curve or list. You can export the report to a medical professional or print it out directly on paper. Plus, you to set the lowest and highest value of pulse rate and so2 rate. When the measured value exceeds the lowest or highest, the device will trigger an alarm on your smartphone.


  • Big OLED screen
  • Lanyard included
  • Support android and apple smartphone
  • Accurate reading


  • App sometimes crashes

Our Recommendation

All the products listed above are FDA-approved and are highly rated by users. However, if you asked for our personal favorite, we recommend going for CMI Health PC-66H. Besides its durability and accuracy, it gives you recording data per 1 second with a continuous power backup for 384 hours. Plus, it gives you a wide range of readings that you rarely find in this price range. Our second pick would be the Emay sleep02 pro and Wellue Checkme 02, as both provide optimum backup and continuous monitoring. If you need something within budget, check out oximeters from Santamedical or Healthtree, as both offer excellent performance at a low price.