# K230587: Wrist Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technology Co., Ltd.
- Decided: Nov 30, 2023 after 273 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.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172366: Wrist Pulse Oximeter, Beijing Choice Electronic Technology Co., Ltd. (2018) Summary page 6.

## Indications for use
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use. The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.

Source page: https://510kreport.com/device/K230587
Methodology: https://510kreport.com/methodology