Which wearable features are FDA cleared
The FDA clears features, not whole watches. Here is every heart, blood pressure, sleep apnea, and blood oxygen feature on a consumer watch, ring, or band that I could find in the FDA's own records.
From Dr. Kenny Civello, cardiologist and electrophysiologist
When the FDA clears a wearable feature, it has reviewed evidence that one specific job, like recording an ECG, works as the company claims. Everything else on the same watch, like sleep scores, stress, or recovery, is a general wellness feature that the FDA does not review.
Cleared or approved
Most wearable features are FDA cleared or granted. Approved is a different, stricter pathway that almost no wearable feature goes through. People often say approved when they mean cleared.
Over the counter
You can buy and use it yourself. A prescription feature has to be ordered by a doctor, even if the ring or watch is sold online.
Who it is for
Each clearance names who the feature is for. Many are only for adults 22 and older, and some only for people without a diagnosis yet.
What the record numbers mean
A number starting with K is a 510(k) clearance, which means the FDA found the feature works like one already on the market. A number starting with DEN is a De Novo grant, used for the first feature of its kind. Each number links to the FDA's own page. A feature can have several numbers when the company updated it.
Cleared wearable features
Tap a category to narrow the list. Where a watch has the feature can depend on the model, your phone, and your country.
Last checked against the FDA databases on October 19, 2026.
| Device | Cleared feature | FDA record | First cleared | How you get it |
|---|---|---|---|---|
| Apple Watch | ECG app | DEN180044, K201525 | Sep 2018 | Over the counter |
| Apple Watch | Irregular rhythm notifications | DEN180042, K212516, K231173 | Sep 2018 | Over the counter |
| Apple Watch | AFib History, for people already diagnosed with AFib | K213971 | Jun 2022 | Over the counter |
| Garmin | ECG app | K221774 | Jan 2023 | Over the counter |
| Google Pixel Watch and Fitbit | ECG app | K200948 | Sep 2020 | Over the counter |
| Google Pixel Watch and Fitbit | Irregular rhythm notifications | K212372 | Apr 2022 | Over the counter |
| KardiaMobile | Personal ECG, single lead and 6 lead | K191406, K211668, K220350 | Jan 2020 | Over the counter |
| Masimo W1 | ECG with AFib detection | K243305 | Apr 2025 | Over the counter |
| Samsung Galaxy Watch | ECG app | K201168, K240909 | Aug 2020 | Over the counter |
| Samsung Galaxy Watch | Irregular heart rhythm notifications | K230292 | May 2023 | Over the counter |
| WHOOP MG | ECG (Heart Screener) | K243236 | Apr 2025 | Over the counter |
| Withings ScanWatch | ECG with AFib detection, and blood oxygen spot checks | K201456 | Oct 2021 | Over the counter |
| Withings ScanWatch | ECG app | K240795 | Jun 2025 | Over the counter |
| Apple Watch | Hypertension notifications, for adults not diagnosed with high blood pressure | K250507 | Sep 2025 | Over the counter |
| Happy Ring | Cuffless blood pressure, adults 22 to 50 | K254000 | Sep 2026 | Check with the maker |
| Hilo Band (Aktiia G0) | Cuffless blood pressure spot checks, calibrated with an arm cuff, adults 22 to 59 | K250415 | Jul 2025 | Over the counter |
| Apple Watch | Sleep apnea notifications | K240929 | Sep 2024 | Over the counter |
| Happy Ring | Home sleep test | K242224 | Jun 2025 | Prescription |
| Samsung Galaxy Watch | Sleep apnea feature | DEN230041 | Feb 2024 | Over the counter |
| Samsung Galaxy Watch and Galaxy Ring | Sleep apnea feature, version 2 | K261011 | Jul 2026 | Over the counter |
| Happy Ring | Health monitoring system | K240236 | Sep 2024 | Prescription |
| Masimo W1 | Blood oxygen and pulse rate spot checks | K232512 | Nov 2023 | Check with the maker |
| Movano EvieMED Ring | Blood oxygen and pulse rate spot checks | K241090 | Nov 2024 | Prescription |
| Google Pixel Watch | Loss of Pulse Detection, which can prompt a call to emergency services | K242967 | Feb 2025 | Over the counter |
Popular wearables with no cleared features
Oura Ring
No FDA clearance found. Oura says the ring is not a medical device.
Ultrahuman Ring
No FDA clearance found.
WHOOP
Only the ECG on WHOOP MG is cleared. Other WHOOP features, including blood pressure estimates, are not.
Garmin
Only the ECG app is cleared. Heart rate alerts, blood oxygen, and sleep features are not.
Hilo Core
Sold as a general wellness product. Not the cleared Hilo Band.
Common questions
Is the Oura Ring FDA approved?
No. Oura has no FDA cleared features. Its sleep, heart rate, and temperature data are general wellness data. That can still be useful, but nothing in it has been reviewed by the FDA.
Is WHOOP FDA approved?
Only one feature. The ECG on WHOOP MG is FDA cleared. Its other features, including blood pressure estimates, are not.
Is there an FDA cleared smartwatch for blood pressure?
Apple Watch has a cleared notification that can flag patterns suggesting high blood pressure. It does not give you a number. The Hilo Band gives readings, but you have to calibrate it with an arm cuff. For checking your blood pressure at home, an upper arm cuff is still the standard. See Best home blood pressure monitor.
Does FDA clearance mean a feature is accurate for me?
It means the company showed the FDA that it works for the people it was tested on, used the way the label says. It can still miss things, and every cleared feature here can be wrong. A doctor still has to confirm a diagnosis.
A company says its product is FDA registered. Is that the same?
No. Registration only means the company told the FDA it exists. It says nothing about whether a feature works. Look for a K or DEN number you can check.
Which watch should I buy?
Start with what you need it to do. The Find the right wearable questions can help you narrow it down. How I choose the wearables I recommend explains how I weigh clearances against everything else.
More on wearables
My watch says I have AFibMy watch ECG says inconclusiveIrregular rhythm notifications, explainedMy watch says my heart rate is high or lowMy watch says I may have sleep apneaFDA cleared or wellness: what the label meansHow I choose the wearables I recommendFind the right wearableBest smartwatch for catching AFibBest smart ring for sleepBest home blood pressure monitorBest personal ECG without a smartwatchBest wearable for an older parentBest wearable for athletesBest wearable without a screenThis page is general education for my patients. It does not replace advice from your own doctor. I checked every record against the FDA 510(k) and De Novo databases on the date shown. Clearances change, so check the FDA links for the latest. Device names are trademarks of their makers. This page is not affiliated with any of them.
Sources: FDA 510(k) Premarket Notification database. FDA De Novo database. FDA, General Wellness: Policy for Low Risk Devices.