Which Pulse Oximeters are FDA-approved?

Which Pulse Oximeters are FDA-approved?

A pulse oximeter is a medical device that measures the level of oxygen in the blood (the so-called saturation indicator).

Regular monitoring of saturation is very important in the presence of pulmonary diseases – asthma, bronchitis, pneumonia.

Due to the rapidly growing demand for pulse oximeters in the past two years due to the spread of coronavirus infection, the number of low-quality, counterfeit, including counterfeit products has also increased on the market.


In a Hurry? My Fast Answer is

Let me tell you about the Wellue O2Ring – it’s like the superhero of pulse oximeters, seriously!

One of the coolest things about it is that it doesn’t just clip onto your finger like your average oximeter.

Wellue O2ring

Nope, it’s a smart ring that you wear on your finger, making it super comfortable and convenient. You won’t even feel like you’re wearing anything special, yet it’s working its magic behind the scenes.

What sets the Wellue O2Ring apart from the pack is its continuous monitoring feature.

Check out their official product page here.

Top FDA-approved Pulse Oximeters

Brand Model FDA Approval Date
Nonin Onyx III 9560 May 2013
Philips IntelliVue MP2/X2 August 2012
Nellcor OxiMax N-600x January 2010
GE Healthcare Ohmeda 3900P October 2009
Masimo Radical-7 August 2009
Medtronic Nellcor N-600x May 2009
Nonin Onyx II 9550 January 2009
Covidien Nellcor N-600x October 2008
Nihon Kohden OLED 930P August 2008
GE Healthcare Ohmeda TruSat May 2008
Nonin Onyx 9500 March 2008
Philips IntelliVue MP5/MP20/MP30 January 2008
Nellcor N-595 September 2007
Covidien Nellcor N-595 June 2007
Masimo Rad-5v March 2007
Nonin Avant 4000 November 2006
Covidien Nellcor N-395 August 2006
Nellcor Oximax N-595 July 2006
GE Healthcare Ohmeda 3700 May 2006


The quality of pulse oximeters must be documented in accordance with the provisions of current legislation.

Pulse oximeters can be classified according to several main features:

  • By scope – household and professional;
  • At the place of measurement – shoulder or wrist;
  • According to the method of operation – stationary and portable;
  • By measurement range;
  • Measurable indicators, etc.

Why Do Pulse Oximeters Need Permit Documents?

Registration and obtaining permit documents of pulse oximeters as well as other medical devices is a state procedure that regulates the release of high-quality, safe and effective medical devices to the market.

As a result of the registration of a medical device, you receive a registration certificate for a medical device

Which Documents Do Pulse Oximeters get?

Pulse oximeters for their legal sale in many countries must have the following types of permits as part of the shipping documentation: (Of course it depends on the country)

  • Registration certificate 
  • Certificate of conformity

Registration certificate

All medical devices put into circulation must be registered with the government in accordance with the requirements of the government.

The registration procedure is quite long and laborious, it is carried out once.

The final document – RC, is issued indefinitely with positive results of the verification. In the future, it does not require re-registration.

To obtain a license, you need to have a complete set of documents for manufactured products.

Certificate of conformity

The technical regulations establish requirements in the field of electromagnetic compatibility.

During the tests, the level of electromagnetic interference generation is evaluated when measuring oxygen in the blood with a pulse oximeter, as well as the stability of the device when exposed to electromagnetic interference generated by other electrical devices.

A certificate is issued both for mass-produced goods and for a batch.

According to the current legislation, all manufacturers of medical devices are required to develop and use a quality management system based on their standards in production(depending on the country).

This certificate allows you to more effectively organize risk management work based on their analysis, documenting processes, optimizing production, reducing scrap, increasing productivity, etc.

It is noteworthy that the implementation of this certificate according to ISO 13485 is mandatory, and the certification of the management system is carried out on a voluntary basis.

What is FDA Approval?

Which Pulse Oximeters are FDA-approved?

The job of the US Food and Drug Administration (FDA) is to tell us what food, pills, or medical devices are safe to consume.

And while many people think that everything that is allowed and approved by the FDA undergoes rigorous testing, in reality this is not always the case.

There is a big difference between pills or medical devices that have been cleared by the FDA and approved by the FDA.

And with more and more electronics going through the hands of the FDA today, it’s important to understand the difference.

FDA Approved Pulse Oximeter FDA Cleared Pulse Oximeter

FDA approved means that “the benefits of a product outweigh its known risks when used appropriately.”

To obtain such approval, manufacturers must apply on the PMA (pre-market authorization) form and attach the results of clinical testing.

In deciding whether to approve the use of a product, the FDA must decide whether its benefits outweigh its risks.

Usually, the FDA tends to approve the use of a high-risk product if there are significant benefits from its use – as, for example, in the case of an artificial heart valve that can save someone’s life.


Class I and II medical devices typically receive an “FDA cleared” when a manufacturer can demonstrate that its product is “substantially equivalent to another similar and legally advertised” device that has already been approved or cleared by the FDA.

Just because the FDA has approved or cleared a device does not mean that it is safe.

This is why you may see class action lawsuit ads looking for people or relatives of people who have been seriously injured or even killed by using FDA-approved products.

Such defective products can end up having a significant impact on health, despite their permission or approval.

It is important to understand that the FDA does not develop products that it evaluates and approves.

It does not conduct its own tests either – it simply reviews the results of tests conducted by independent laboratories and clinics to determine whether a device, pill or dietary supplement is as safe and effective as the manufacturer claims…

My Favorite FDA-Approved Oximeters

While today at the market there are so many pulse oximeters, so many of them are not often medically-approved devices and created for sport or recreational use.

 So it goes without saying that devices without medical proven papers can be inaccurate. Anyway if you are not a sick person , these devices can be a good helper of the state of your health if you start showing first anxious symptoms…

Today I want to present the list of TOP 3 tested pulse oximeters brands with accurate results and reliable enough

1.Wellue pulse oximeters

Wellue is a trademark and brand of Shenzhen Viatom Technology. It is a Chinese health-tech company Shenzhen Viatom Technology.

Wellue O2Ring Oxgyen Monitor Smart Ring Sleep Apnea Monitor

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The company focuses on innovative medical products. Wellue Brand is a professional company of healthcare experts and modern innovators that bring healthier and longer life to all of us.

The Top Sale Product is the Wellue O2 Ring .

I think it is the latest technology of pulse oximeters.

Wellue O2 Ring is an FDA approved pulse oximeter. It is a tracker ring for monitoring blood oxygen saturation levels and heart rate throughout the night and day; SpO2 and heart rate sensors;

It is the best choice for overnight oxygen saturation monitoring and health monitoring.

It has accurate tracking of all indicators and very common features such as oximetry Technologies, waterproof resistance, smart alarms and saturation alerts. 

The device is simple and reliable in operation so that it can be used at home without special technical and medical knowledge.

2 .Zacurate Pulse Oximeter 

Zacurate is a FDA Cleared Pulse Oximeter with the best price under $20

Definitely choose the Zaccurate fingertip pulse oximeter which is a top selling oximeter today and what was made for professional sportsmen and for mass screening examinations to use at home for self-monitoring of saturation of patients in various pathological conditions that cause hypoxia.

3 .Innovo Fingertip pulse oximeter

This pulse oximeter is light and very compact, it has a low power consumption, convenient operation, and is portable.

It is an FDA approved product .The device is made of high-strength materials, is waterproof, and does not break after being dropped. Removable silicone covers are used to protect against mechanical damage and water.

Device turns on automatically as soon as a finger is inserted into the device. This feature is especially useful in emergency situations where you need to check your SpO2 level or pulse value urgently.

The devices are easy in operation and simple, reliable in operation so that they can be used at home without special technical and medical knowledge.

4. Contec Pulse Oximeter

The wrist pulse oximeter features a color, multi-direction OLED (organic light-emitting diode) screen with four levels of brightness.

This is an accurate device for measuring blood oxygen saturation (SpO2) and heart rate. It is intended for use in medical institutions, as well as at home.

The pulse oximeter has an alarm in the following cases:

The design is comfortable and fits pediatric and adult users. Simple and easy-to-use wrist-worn design.


Which pulse oximeters are FDA cleared?

Pay attention to Wellue Pulse Oximeters, Zaccurate, Innovo and Contec Pulse Oximeter.

These are tested pulse oximeter brands with accurate results and reliable enough products.

Which is the most reliable pulse oximeter?

The Wellue O2 ring is the best choice for overnight oxygen saturation monitoring and health monitoring.

It has accurate tracking of all indicators and very common features such as oximetry Technologies, waterproof resistance, smart alarms and saturation alerts.

The device is simple and reliable in operation so that it can be used at home without special technical and medical knowledge.

Which oximeter do hospitals use?

Stationary monitors-pulse oximeters are usually used at hospitals.

They provide a highly accurate measurement, which is recorded in the form of graphs.