5 Best FDA Approved Ketone Meters for Breath & Blood (2024)

FDA approved ketone meters meet safety and effectiveness standards established by the FDA for medical devices.

This is especially important for anyone following the ketogenic diet. Here are the top FDA certified breath and blood meters on the market right now.

Top Options

FDA Approved Ketone Meters

1. Biosense Ketone Breath Meter

Pros

• FDA-registered Class I medical device backed by clinical trial data
• Most accurate ketone breath meter on the market
• Uses end-of-breath sampling for the most accurate reading
• Has a screen, so you don’t need to use a smartphone first thing in the morning
• Automatically syncs with the app for convenient tracking
• Haptic feedback tells you when to stop breathing into the device

Cons

• Takes time to warm up before you can use it
• Average battery life of 2-4 days
• $74.99 for recalibration every 6+ months

Biosense is the best FDA approved ketone breath meter on the market. It was launched as an FDA Class 1 medical device after a successful 2019 clinical trial. (1)

This enabled pharma and academic researchers and clinicians to monitor patient dosing of therapeutic ketosis (area-under-the-curve) in several therapeutic areas, including metabolic, neurocognitive, and oncology. 

• What sets Biosense apart is its unique “deep lung sampling” method. Unlike regular breath analysis, this technique measures acetone from the end of your breath, resulting in super accurate readings. 

• Another plus is the device’s built-in display which shows your results without needing a phone. No more squinting at a screen first thing in the morning! 

The Biosense meter measures your acetone levels in units called ACEs. There’s a rough 1:10 relationship between ACEs and Beta-hydroxybutyrate. 

For example, 5 ACEs equal roughly 0.5 mmol/L of blood ketone levels. 

A minor downside is its warm-up time and average battery life. Plus, there’s a $74.99 recalibration fee every 6+ months. But, for the accuracy and convenience, it’s well worth it. 

2. Fora 6 Connect Blood Ketone Meter

Pros

• FDA-approved provides fast and accurate readings in 5-10 seconds
• The bundle kit offers a lot of value for the money
• Syncs and tracks data on your smartphone, tracks 1,000 recent results
• The app also calculates the GKI index and Dr. Boz’s ratios
• Measures blood glucose, blood ketone, hematocrit, hemoglobin, total cholesterol, and uric acid
• Strip ejection design removes strips without contact, minimizing cross infection

Cons

• Doesn’t come with alcohol swabs
• Doesn’t have an attractive design
• The Fora app has low ratings in the App Store 2.1 stars and Google Play 2.8 stars

Fora 6 Connect is the best FDA approved blood ketone meter on the market. (2)

It measures blood ketones, blood glucose, hematocrit, hemoglobin, total cholesterol, and uric acid. It’s pretty impressive for a device that’s so compact. 

The Connect also uses Gold Advance Strip technology, meaning it’s super accurate and reliable. 

There’s also a strip ejection design that’s great for keeping things clean and reducing the chance of cross-infection. 

You can store up to 1,000 test results in its memory and set up to 4 alarms to remind you to take your measurements. 

It also has a Bluetooth connection that lets you sync and track your data on your smartphone. 

Plus, the app calculates the GKI index and Dr. Boz ratio, which is super useful if you’re on a ketogenic diet. 

The main downsides are that the design isn’t the most appealing, and the Fora app has very low ratings in the App Store 2.1 stars and Google Play 2.8 stars.

3. Keto Mojo Blood Ketone Meter

Pros

• FDA-approved, ensuring a high level of accuracy
• Easy to track measurement data through the smartphone app
• Tracks blood glucose and blood ketones
• Customer support was super responsive and helped me out quickly when I ordered the wrong item
• Comes with a control solution to verify that the device is calibrated
• The promo bundle kit offers a lot of value for the money

Cons

• Strips are individually packaged and quite difficult to open
• GKI readings are available only through the app, not the meter screen
• The app does not automatically import results, manual sync is needed every time
• Kit’s doesn’t have alcohol swabs to clean the finger

The Keto-Mojo is an FDA approved blood ketone meter. It’s a class II medical device for self-testing of glucose and ketone levels, suitable for testing for Type 1, Type 2, and gestational diabetes. (3)

The meter is manufactured in an FDA-inspected and approved establishment that also conforms to ISO:9001 manufacturing practices. The meter also conforms to ISO 15197:2013 standards.

One cool feature is its Bluetooth integration. You can sync your measurements with your smartphone, although it requires manual syncing. 

It also comes with up to 5 daily alarm settings. So, you’ll never forget to take your measurements!

Another bonus is the back-lit display and strip port light, making it easy to use even in low light. 

However, a downside is that the strips are individually packed, which makes them tricky to open. 

4. Ketoscan Mini Ketone Breathalyzer

Pros

• Has an on-device screen (dot matrix display)
• Is an FDA Class I medical device
• Has a built-in self-diagnostics module
• The app is free and comes with tips and tricks for measuring breath
• Compact size and easy to use

Cons

• Need to replace the sensor and recalibrate after every 320 breath tests
• Slow warmup time before you can use the device
• Often need to do a “calibration blow” before starting to use the device
• Smartphone connection problems

The Ketoscan Mini is a FDA approved ketone analyzer. It’s an FDA Class I medical device that makes measuring ketones a breeze. No longer do I have to prick my finger for readings. (4)

It was tested at the Vienna University of Technology and got a positive score of 95% prediction rate on all 450 measurements taken. (5)

But it isn’t perfect. After 320 breath tests, I had to shell out $30 for recalibration and sensor replacement. 

Despite that, it’s a non-invasive way to understand whether my body is burning fat or carbs for energy. 

Ketoscan Mini is made in Korea and takes just about 45 seconds to load up and then another 5 seconds to analyze my breath. 

What I appreciate most is its compact size and the built-in screen. It also comes with an easy-to-use app. 

So I don’t have to squint at my smartphone screen first thing in the morning. It’s not without its flaws, but overall, the Ketoscan Mini is pretty handy. 

5. Ketonix Ketone Breath Analyzer

Pros

• FDA approved ketone tracker
• Oldest known breathalyzer brand on the market
• Sensor doesn’t need to be replaced
• Easy to use and practical smartphone app
• Compact design and perfect to use on the go

Cons

• Device doesn’t have a screen, so you always need to use a smartphone
• Paid software upgrade features come free with Keyto and Biosense meters
• Takes up to 5 minutes for warm-up, depending on the room temperature

The Ketonix is an FDA approved keto breath analyzer. Ketonix is the oldest breath monitor brand available on the market. (6)

The company behind Ketonix is based in Sweden and was founded by a man who had epilepsy. 

This shows the genuine intent behind the creation of the device. It’s designed to truly assist people in their health journey. 

The device is user-friendly with its Bluetooth, WIFI, and USB connections, but it does require a smartphone app for operation as it lacks a screen. 

This can be a bit troublesome if you’re trying to minimize screen time.

In terms of features, Ketonix offers software upgrades, including an analysis package, a macro calculator, and even recipes. 

However, these come at an additional cost, unlike other ketone meters like Keyto and Biosense, where these features are free. 

The package includes the Ketonix device, a travel pouch, a charging cable, and two mouthpieces, making it a compact and convenient option for those on the go.