# K211143: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Brav Electronic Technologies Co., Ltd.
- Decided: Jul 17, 2023 after 822 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173123: Pulse Oximeter, Shenzhen Imdk Medical Technology Co., Ltd. (2018) Summary page 4.

## Indications for use
The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.

Source page: https://510kreport.com/device/K211143
Methodology: https://510kreport.com/methodology