# K152089: Wrist Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
- Decided: Aug 17, 2016 after 387 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)
- K122046: Wrist Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2013) Summary page 4.

## Indications for use
The Wrist Pulse Oximeter is intended for spot checking in measuring and displaying oxygen saturation of functional arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patients in hospitals, hospital facilities and home healthcare environments.

Source page: https://510kreport.com/device/K152089
Methodology: https://510kreport.com/methodology