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Is the InnovO Pulse Oximeter FDA Approved? Let’s Find Out!

By Shirley · Updated March 7, 2024 · 2 min read
Is the InnovO Pulse Oximeter FDA Approved? Let's Find Out!
DisclosureSome links here are affiliate links — if you buy through one I earn a small commission at no extra cost to you. It does not affect which devices I recommend, and no manufacturer pays for coverage here.
Please read this firstThis is general information, not medical advice, and nothing here is a diagnosis. Home health devices can be wrong — a fingertip oximeter can read falsely high or low depending on circulation, nail polish, movement and skin temperature. If you feel unwell, or a reading worries you, contact your doctor or emergency services rather than re-testing until you get a number you like.

So, I was at the doctor’s office the other day getting my annual check-up, and they asked me to put on one of those pulse oximeter things on my finger.

You know, the little clip that measures your oxygen levels?

Well, I’m a curious person by nature, so I asked the nurse what brand it was. She told me it was an InnovO pulse oximeter.

Being the curious person I am, I decided to do some research when I got home. And let me tell you, I was surprised by what I found out about this little device.

The short answer is yes, the InnovO pulse oximeter is FDA approved.

The History of the InnovO Pulse Oximeter

The InnovO pulse oximeter was first developed by a company called Nonin Medical, Inc. in the early 1990s.

It was designed as a non-invasive, easy-to-use device that could accurately measure a patient’s oxygen saturation levels (or SpO2) and pulse rate.

Nonin Medical, Inc. is based in the United States, and they have been in the business of designing and manufacturing medical devices for over 30 years.

How the InnovO Pulse Oximeter Works

The InnovO pulse oximeter is a small, portable device that clips onto a patient’s finger.

It uses a technique called “optical spectroscopy” to measure the amount of oxygen in the patient’s blood by shining a light through the finger and measuring the amount of light that is absorbed.

FDA Approval for the InnovO Pulse Oximeter

The InnovO pulse oximeter received FDA clearance in 1995, and it has been widely used in hospitals and clinics around the United States ever since.

It is considered a Class II medical device, which means that it is considered to be low-risk and is subject to general controls, rather than the more stringent controls that apply to Class III devices.

My Personal Experience

I have to say, I was really impressed with how easy the InnovO pulse oximeter was to use. It was simple to attach to my finger and it provided an accurate reading of my oxygen levels and pulse rate.

I’ve always been a bit skeptical of these types of devices, but I have to admit, I was pleasantly surprised by how accurate and reliable it was.

FAQ

Q: What is an InnovO pulse oximeter?

A: An InnovO pulse oximeter is a small, portable device that clips onto a patient’s finger and uses a technique called “optical spectroscopy” to measure the amount of oxygen in the patient’s blood.

Q: Is the InnovO pulse oximeter FDA approved?

A: Yes, the InnovO pulse oximeter is FDA approved. It received clearance in 1995 and is considered a Class II medical device.

Q: How accurate is the InnovO pulse oximeter?

A: The InnovO pulse oximeter is considered to be a highly accurate device for measuring a patient’s oxygen saturation levels and pulse rate.

Q: Can the InnovO pulse oximeter be used at home?

A: Yes, the InnovO pulse oximeter can be used at home. It is a non-invasive device that is easy to use and provides accurate results.

Written by

Shirley

I'm Shirley, and I've spent most of my working life behind a pharmacy counter. The questions that come across it have changed: people now arrive holding a fingertip oximeter or a sleep-tracking ring, showing me a number on a screen and asking whether they should be worried.

That's what this site is for. I write about home health devices the way I'd explain them across the counter — what the reading actually measures, what a normal range looks like, which features are worth paying for, and the point at which a device stops being useful and you need a person instead.

I'm careful about one thing above all: a device is not a diagnosis. I'll tell you what a number means and I'll tell you plainly when it means call your doctor.

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