# K191417: Belun Ring

- Pathway: 510(k) (Traditional)
- Applicant: Belun Technology Company Limited
- Decided: Oct 10, 2019 after 135 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: 4 generations back to K001085 (2000). 4 ancestors in all.
3 later devices descend 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)
- K180174: Belun Ring, Belun Technology Company Limited (2018) Summary page 4.

## Most influential descendants
- K211407: Belun Ring BLR-100X (2021), 2 descendants of its own
- 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-100C is a non-invasive and stand-alone pulse oximeter, intended to be used for spot-checking and/or 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. It is not intended for single-use and out-of-hospital transport use.

Source page: https://510kreport.com/device/K191417
Methodology: https://510kreport.com/methodology