# K172366: Wrist Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technology Co., Ltd.
- Decided: Mar 16, 2018 after 224 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: 5 generations back to K001085 (2000). 5 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081125: Wrist Pulse Oximeter MD300W, Beijing Choice Electronic Technololgy Co., Ltd. (2008) Summary page 5.

## Most influential descendants
- K191088: Checkme O2 Pulse Oximeter (2019), 2 descendants of its own
- K242876: Pulse Oximeter ( PO2, PO2A, PO2B) (2025), 0 descendants of its own
- K240808: Pulse Oximeter (WS20A) (2024), 0 descendants of its own
- K230587: Wrist Pulse Oximeter (2023), 0 descendants of its own
- K213515: WesperO2 (2022), 0 descendants of its own

## Indications for use
MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use.

Source page: https://510kreport.com/device/K172366
Methodology: https://510kreport.com/methodology