Identity
- Trade Name
- circul pro, small FDA UDI
- Generic Name
- Wearable multiple physiological parameter recorder, reusable FDA UDI
- Device Name
- The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for comfort. It can be worn on either hand. The ring has a retractable spring design, which automatically adjusts the tightness of the ring and fixates the sensor array to the wearer’s finger. The ring has advanced photoelectric signal detection and processing methods which detect and analyze blood oxygen saturation and pulse rate. The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions. FDA UDI
- Model / Reference
- O2-77-MS FDA UDI
- Description
- The circul pro Ring is a small, wearable, non-invasive device to be worn on one finger which features an adjustable fit for comfort. It can be worn on either hand. The ring has a retractable spring design, which automatically adjusts the tightness of the ring and fixates the sensor array to the wearer’s finger. The ring has advanced photoelectric signal detection and processing methods which detect and analyze blood oxygen saturation and pulse rate. The circul™ pro Ring is a wireless, non-invasive, and stand-alone pulse oximeter intended to be used for spot-check and/or continuous data collection of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) through the index finger in adult patients. It can be used in hospitals and home environments for up to twelve hours in non-motion and well perfused conditions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850033422061 FDA UDI
- 510(k) Number
- K221361 FDA UDI
- FDA Product Code
- DQA FDA UDI
- GMDN Term
- Wearable multiple physiological parameter recorder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2700 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 18 Millimeter FDA UDI
Category: Wearable multiple physiological parameter recorder, reusable
circul pro, small by Bodimetrics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable multiple physiological parameter recorder, reusable.
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- Wearable Patch — ATLAS LIFT TECH, INC. · Class I
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- SOMNOwatch plus ACTI — Somnomedics GmbH · Class II
- PLM Sensor Set — Somnomedics GmbH
Cleared under the same submission
K221361 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Bodimetrics, LLC
Sources (1)
- FDA UDI 31023aab-b351-4b1a-8edb-b9772188fd90 37 fields · synced Jun 8, 2026