# K250837: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Berry Electronic Tech Co., Ltd.
- Decided: Sep 25, 2025 after 189 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: 11 generations back to K910772 (1991). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181503: Fingertip Pulse Oximeter, Beijing Choice Electronic Technology Co., Ltd. (2018) Summary page 6.

## Indications for use
The Pulse Oximeter is intended for spot-checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child users in hospitals, hospital facilities and home healthcare environments.

Source page: https://510kreport.com/device/K250837
Methodology: https://510kreport.com/methodology