# K211407: Belun Ring BLR-100X

- Pathway: 510(k) (Traditional)
- Applicant: Belun Technology Company Limited
- Decided: Oct 21, 2021 after 168 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: 5 generations back to K001085 (2000). 5 ancestors in all.
2 later devices descend from it; 2 cite 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)
- K191417: Belun Ring, Belun Technology Company Limited (2019) Summary page 4.

## Most influential descendants
- K221361: circul™ pro Ring (2023), 1 descendant of its own
- K234110: Belun Ring BLR-200 (BLR-200) (2024), 0 descendants of its own

## Indications for use
Belun Ring BLR-100X is a wireless, non-invasive and stand-alone pulse oximeter intended to be used for 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 not have alarms.

Source page: https://510kreport.com/device/K211407
Methodology: https://510kreport.com/methodology