# K152091: Fingertip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
- Decided: Aug 18, 2016 after 388 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: 10 generations back to K910772 (1991). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142888: Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2015) Summary page 4.

## Indications for use
The Fingertip Pulse Oximeter is intended for spot checking in measuring and displaying 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/K152091
Methodology: https://510kreport.com/methodology