# K202324: Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Bsx Technology Electronics Co., Ltd.
- Decided: Dec 14, 2020 after 119 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)
- K191430: Pulse Oximeter, Shenzhen Yimi Life-Technology Co., Ltd. (2019) Summary page 4.

## Indications for use
The Fingertip Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults or children over three years old in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

Source page: https://510kreport.com/device/K202324
Methodology: https://510kreport.com/methodology