# K201384: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Raysintone Technology Co., Ltd.
- Decided: Dec 7, 2020 after 195 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 a reusable non-invasive device intended for the spot checking of oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate of adult patients in hospital and other healthcare environments. And it is not intended to be used under motion or low perfusion scenarios.

Source page: https://510kreport.com/device/K201384
Methodology: https://510kreport.com/methodology