Updated November 2026
This guide lists smart rings that have an FDA 510(k) clearance for SpO2 (blood oxygen) measurement, with the K-number so you can check each record yourself. We use "FDA-cleared" only for rings with a 510(k) for SpO2. FDA clears these devices; it does not "approve" them. Rings without that clearance are listed separately as wellness devices.
This article is general information, not medical advice. If you are worried about your oxygen levels or breathing, talk to a clinician. In an emergency, call 911 (US) or 112 (EU).
Quick Comparison: Rings with an FDA 510(k) for SpO2
| Feature | EvieMED Ring (Movano Health) | Wellue O2Ring (Viatom) | RingConn (Ninenovo) |
|---|---|---|---|
| FDA 510(k) number | K241090 | K242876 | K260490 |
| FDA decision date | Nov 29, 2024 | Feb 28, 2025 | Oct 2, 2026 |
| Name on the FDA record | Evie Med Ring | Pulse Oximeter (models PO2, PO2A, PO2B) | Ninenovo Blood Oxygen Ring |
| Prescription status | Prescription (per FDA record) | Not stated in the FDA summary we reviewed | Prescription (per FDA comparison table) |
| Cleared for | SpO2 measurement in adults | SpO2 measurement in adults | SpO2 measurement in adults |
| Use described by FDA | Spot checking SpO2 and pulse rate of adult users with a condition that might benefit from monitoring, in no-motion conditions | Spot-check and/or continuous data collection, not continuous monitoring | Spot-check and/or continuous data collection through the index finger, up to 12 hours in non-motion, well-perfused conditions; no alarms |
| Sleep SpO2 tracking | FDA record describes spot checking | FDA record allows continuous data collection, and names sleep labs and home use | FDA record allows continuous data collection, up to 12 hours |
| Accuracy (with source) | 2.46% pooled RMSE in a company-reported pivotal trial submitted to FDA (Movano, 2024) | ARMS 1.77% under no motion, in healthy adult volunteers across 70% to 100% SpO2 (FDA record) | ARMS under 3% in steady state across 70% to 100% SpO2, in 19 healthy adults aged 18 to 45 (FDA record) |
| Battery | See manufacturer | See manufacturer | See manufacturer |
| Price | See manufacturer | See manufacturer | See manufacturer |
Accuracy figures come from the trials described in each source, in specific conditions and populations. They are not a guarantee of how a ring will perform on you.
Best FDA-Cleared Smart Rings with Oximeters in 2026
Three rings have an FDA 510(k) for SpO2 measurement in adults that we could verify. The right one depends on how you plan to use it, so read the FDA-described use above before you buy.
EvieMED Ring by Movano Health
The FDA record (K241090) covers spot checking of SpO2 and pulse rate in adult users with a condition that might benefit from monitoring, in no-motion conditions. FDA describes it as available with a prescription and without alarms. Only the pulse oximeter function is FDA-cleared; other EvieMED features are wellness. Availability: check with the manufacturer.
Wellue O2Ring by Viatom
The FDA record (K242876) covers measuring SpO2 and pulse rate in adults for "spot-check and/or continuous data collection, not continuous monitoring." It is not cleared for children. FDA record K242876 covers Viatom's Pulse Oximeter (PO2/PO2A/PO2B); Viatom identifies the PO2 as the Wellue O2Ring. Check the SKU you buy.
RingConn
FDA lists the clearance (K260490, October 2, 2026) under the device name "Ninenovo Blood Oxygen Ring," and the company announced it as a 510(k) clearance for non-invasive SpO2 measurement. The record describes adult use only, lists it as a prescription device and says it has no alarms.
Not FDA-Cleared for SpO2 (Wellness Rings)
Popular wellness rings can show blood-oxygen or sleep trends, but we do not call them FDA-cleared for SpO2. Their readings are useful for noticing patterns, not for medical decisions.
| Ring | SpO2 status | Note |
|---|---|---|
| Oura | No FDA 510(k) for SpO2 found (Nov 2026) | Wellness feature |
| Ultrahuman | No FDA 510(k) for SpO2 found (Nov 2026) | Wellness feature |
| Samsung Galaxy Ring | Not cleared for SpO2 measurement | Samsung's FDA clearance relates to a separate software feature, not to SpO2 measurement |
What FDA Clearance Means (and Does Not)
- A 510(k) clearance means FDA found the device substantially equivalent to a legally marketed predicate device.
- Clearance applies only to the indications for use in the record, such as adults only, specific settings and specific conditions like non-motion.
- Clearance for SpO2 measurement is not clearance to diagnose or treat any condition.
- You can check any claim yourself by searching the FDA 510(k) database for the K-number.
Using Ring Data with an AI Health Coach
Healify's AI health coach is a general wellness coach. If your ring shares data through Apple Health, your Healify coach can use your sleep and activity data to suggest what to do next. Healify is not a medical device. It doesn't diagnose, treat, monitor or prevent any disease, and it does not replace the FDA-cleared measurement from a ring. Healify is in private beta: join the waitlist for early access.
FAQs
Are smart rings FDA-approved?
FDA clears most pulse oximeters through the 510(k) pathway, so the correct word is cleared, not approved. A 510(k) clearance means FDA found the device substantially equivalent to a legally marketed predicate for the indications stated in the record. Each clearance is limited to those stated indications.
Which smart rings are FDA-cleared for SpO2?
Based on the FDA 510(k) database, the EvieMED Ring (K241090), the Wellue O2Ring from Viatom (K242876) and the RingConn smart ring (K260490, listed by FDA as the Ninenovo Blood Oxygen Ring) are cleared for SpO2 measurement in adults. Check each record for the exact indications for use.
Is the Oura Ring FDA-cleared for SpO2?
No. Oura is not FDA-cleared for SpO2. Its blood-oxygen readings are a wellness feature and should not be used to make medical decisions.
Can I use a smart ring to diagnose a health condition?
No. This guide covers SpO2 measurement only, and the FDA records describe measurement of SpO2 and pulse rate in adults. A ring cannot diagnose a condition. If you are worried about your oxygen levels or breathing, talk to a clinician.