# K202173: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen AOJ Medical Technology Co., Ltd.
- Decided: Dec 7, 2020 after 126 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.
1 later device descends from it; 1 cites it directly.
0 of 9 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.

## Most influential descendants
- K232520: Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH (2024), 0 descendants of its own

## Indications for use
The pulse oximeter is a reusable 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.

Source page: https://510kreport.com/device/K202173
Methodology: https://510kreport.com/methodology