Wondering where to buy a truly FDA approved oximeter? Want to avoid the false FDA clearance claims?

We got you.

This guide is an ultimate one-stop solution for all buyers.

Here, you will learn:

• What is an FDA-approved pulse oximeter
• Places that sell FDA-approved oximeters
• How to make sure an oximeter is FDA cleared 

However, before we dive deeper, you may want to review how to use a pulse oximeter.

Now, let’s begin!

What is an FDA Approved Pulse Oximeter

The first step to buying the right pulse oximeter is understanding what FDA approval means and why it matters. 

Similar to all medical devices, FDA clearance ensures the reliable performance of a pulse oximeter. An oximeter that clears through the FDA 510(k) process ensures that the device delivers accurate SpO2 readings across various ages, genders, and skin colours. 

While there are numerous retailers selling oximeters, many of these devices falsely claim FDA clearance and may only provide a vague estimate of your SpO2 level.

This can put individuals with a medical condition at risk where clinical-grade accuracy is critical, especially when managing heart and respiratory health. 

Therefore, it is important to buy medically tested pulse oximeters for home use. 

Where to Buy FDA Approved Oximeter

Through careful screening, we have gathered the safest and most reliable options when it comes to buying an FDA-cleared oximeter:

1. Manufacturers Official Websites

It is less likely for a manufacturer to falsely list an oximeter having FDA clearance on the official website. So authenticity is often guaranteed when buying directly from manufacturers, making this the safest option.

Take Nonin Medical’s TruO2 as an example – considered the best pulse oximeter available over the counter and cleared by the U.S. Food and Drug Administration (FDA)​ , as stated on their official website. 

Oximeters purchased from the official website ensure complete warranty and expert support, but handling charges might add up when shipped globally, resulting in a higher overall product cost.

2. Licensed Pharmacies 

Licensed online pharmacies source pulse oximeters directly from verified distributors, so encountering fakes is rare, but availability can vary by country. Some of the trusted sites include:

1. Walgreens.com

Platform type: Online and in-store

Stock Variety: New and wide

Return policy: 30 day return and exchange on health products.

As one of the largest pharmacy chains, there is a large variety of pulse oximeter Walgreens has to offer including both adult and infant pulse oximeter. 

It is a decent option if you have a small budget and do not wish to stress about repackaged or refurbished models being sold to you.

But since a large number of these over-the-counter oximeters are not FDA-approved, consider a box inspection to locate the 510(k) clearance number before purchasing.   

2. CVS Pharmacy

Stock Variety: Few, curated FDA options

Platform type: Online and in-store

Return policy: Offers 60 days return and exchange on unopened or defective products

This one is another trusted pharmacy with easy in-store backup and pharmacist support for first-time pulse oximeter buyers. 

But at CVS, pulse oximeter options for FDA approved oximeters might be limited and can often be expensive for first time buyers. 

Similar to Walgreens, FDA approval is not guaranteed for their pulse oximeters, so you will require pharmacist guidance to make sure the product is 510(k) cleared.  

3. Ecommerce Platforms 

E-commerce retailers like Amazon are the most accessible places to shop for FDA-approved pulse oximeters. 

While FDA-cleared pulse oximeters can be pricey for first-time buyers, ecommerce websites like Amazon and Walmart frequently offer discounts on FDA-cleared models. 

Not only do they offer a variety of oximeters at affordable prices, but buyers can also go through real user reviews to judge the reliability and quality of each device.

1. Walmart 

Platform type: Online and in-store

Stock Variety: Limited

Return policy: Offers a 30-day window for product returns at both its physical and online stores.

Walmart operates both physical stores and ecommerce platforms, so those who are not comfortable with online purchases also have the option to shop in-store.

You may need to be vigilant when buying pulse oximeters from Walmart since users often report devices being defective or falsely claiming to be FDA cleared. 

Due to a lack of expert guidance from the staff, you may also be susceptible to buying refurbished devices when shopping for pulse oximeters, both in-store and online. 

2. Amazon

Platform type: Online

Stock Variety: Wide, curated FDA options

Return policy: Free 30 days returns and exchange on unopened or defective health products.

Known for its wide variety of products, Amazon remains the go-to option for all buyers. 

At Amazon pulse oximeter holding FDA clearance can be found using an array of product filters. Buyers also can read through thousands of product reviews on the best sellers making the platform trustworthy for online purchases.

Buying FDA approved pulse oximeters on Amazon is also very economical as products frequently go on sale with discounts on their website.

But just like all e-commerce retailers, you need a great deal of research when it comes to buying a medical-grade pulse oximeter. 

Because even if a product is listed as FDA cleared, you might occasionally come across fakes now and then since the platform lacks a physical store where you can inspect products firsthand.

Here are some of our picks for the best pulse oximeters from Amazon:

How to Check if a Pulse Oximeter is FDA Approved

Before choosing a pulse oximeter, ensure the model is listed on the FDA’s official site. There are two ways to do that:

Go to fda.gov and navigate to ‘Device Approvals and Clearances’ and scroll down to find the list of medical devices approved each year. Both adult and pediatric pulse oximeter can be found on the website.

Alternatively, you can search the model in the 510(k) premarket notification database and find the model’s (510k) clearance number mentioned on the box packaging of the oximeter. Enter the clearance number (i.e., K214115 for the Masimo MightySat Medical pulse oximeter) into the FDA’s 510(k) database, and you can verify if it’s FDA approved.

FAQ

3. How to attach a pulse oximeter to a pediatric

For a paediatric fingertip pulse oximeter, attach the sensor clip to a warm bare finger of the paediatric; whereas for sock oximeters, secure the wrap around the foot so it fits snugly, connect the cable and hold still for 1 to 2 minutes. 

4. Where can i buy a pediatric pulse oximeter

• Amazon/Walmart for budget frindly options
• Walgreens/CVS in-store for authentic and reliable options