# K234110: Belun Ring BLR-200 (BLR-200)

- Pathway: 510(k) (Traditional)
- Applicant: Belun Technology Company Limited
- Decided: Oct 11, 2024 after 289 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: 7 generations back to K001085 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
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 5.
- K221361: circul™ pro Ring, Bodimetrics, LLC (2023) Summary page 5.

## Indications for use
Belun Ring BLR-200 is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for spot-checking and/or continuous data collection and recording of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients through index finger in hospital and home environment for up to ten hours, during no motion and motion conditions, and for patients who are well or poorly perfused. It is not intended for single-use and out-of-hospital transport use and does ot have alarms.

Source page: https://510kreport.com/device/K234110
Methodology: https://510kreport.com/methodology