# K221361: circul™ pro Ring

- Pathway: 510(k) (Traditional)
- Applicant: Bodimetrics, LLC
- Decided: Aug 29, 2023 after 475 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001085 (2000). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211407: Belun Ring BLR-100X, Belun Technology Company Limited (2021) Summary page 4.

## Most influential descendants
- K234110: Belun Ring BLR-200 (BLR-200) (2024), 0 descendants of its own

## Indications for use
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 (Sp02) 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. It is not intended for single-use and out-of-hospital transport use and does not have alarms.

Source page: https://510kreport.com/device/K221361
Methodology: https://510kreport.com/methodology