# K191430: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Yimi Life-Technology Co., Ltd.
- Decided: Oct 18, 2019 after 142 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.
7 later devices descend from it; 5 cite it directly.
0 of 14 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.

## Most influential descendants
- K212665: Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) (2022), 1 descendant of its own
- K202173: Pulse Oximeter (2020), 1 descendant of its own
- 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
- K240092: Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) (2024), 0 descendants of its own
- K230277: Pulse Oximeter (Model OHT60,OXH78) (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/K191430
Methodology: https://510kreport.com/methodology