# K172141: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Berry Electronic Tech Co., Ltd.
- Decided: Apr 4, 2018 after 261 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: 16 generations back to K941811 (1994). 105 ancestors in all.
No later device cites it as a predicate yet.
0 of 106 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141362: Pulse Oximeter CMS50EW, Contec Medical Systems Co.,Ltd (2015) Summary page 5.

## Indications for use
The pulse oximeter (BM1000 & BM1000C) is designed for spot checking of the functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

Source page: https://510kreport.com/device/K172141
Methodology: https://510kreport.com/methodology