# K213430: Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Witleaf Medical Electronics Co., Ltd.
- Decided: Dec 30, 2022 after 435 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: 8 generations back to K001085 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203854: Pulse Oximeter, Shenzhen Hexin Zondan Medical Equipment Co., Ltd. (2021) Summary page 4.

## Indications for use
This Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). It is indicated for adult patients in home and hospital environment. The device is not intended for continuous monitoring, use during motion or use with low perfusion.

Source page: https://510kreport.com/device/K213430
Methodology: https://510kreport.com/methodology