# K203854: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Hexin Zondan Medical Equipment Co., Ltd.
- Decided: Apr 23, 2021 after 113 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)
- K163135: Finger Pulse Oximeter, Shenzhen Fitfaith Technology Co.,Ltd (2017) Summary page 5.

## Most influential descendants
- K213430: Fingertip Pulse Oximeter (2022), 0 descendants of its own

## Indications for use
The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).

Source page: https://510kreport.com/device/K203854
Methodology: https://510kreport.com/methodology