# K213431: Handheld Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Witleaf Medical Electronics Co., Ltd.
- Decided: Feb 26, 2023 after 493 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: 14 generations back to K941811 (1994). 122 ancestors in all.
No later device cites it as a predicate yet.
1 of 123 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201468: Pulse Oximeter, Shenzhen Creative Industry Co., Ltd. (2021) Summary page 5.

## Indications for use
This Handheld Pulse Oximeter is intended for measuring and recording the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check of SpO2, PR of adult patients in hospitals, clinics, or home. This device is not intended for continuous monitoring, use during motion or use with low perfusion.

Source page: https://510kreport.com/device/K213431
Methodology: https://510kreport.com/methodology