# K122046: Wrist Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Feb 4, 2013 after 207 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.
3 later devices descend from it; 2 cite 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)
- K081125: Wrist Pulse Oximeter MD300W, Beijing Choice Electronic Technololgy Co., Ltd. (2008) Summary page 1.

## Most influential descendants
- K132407: Vital Signs Patch System (in Short VSP) (2014), 1 descendant of its own
- K152089: Wrist Pulse Oximeter (2016), 0 descendants of its own
- K151835: Vital Signs Patch System (2016), 0 descendants of its own

## Indications for use
The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in intemnist/ surgery, Anesthesia, intensive care and etc).

Source page: https://510kreport.com/device/K122046
Methodology: https://510kreport.com/methodology