# K142687: Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Berry Electronic Tech Co., Ltd.
- Decided: Apr 13, 2015 after 203 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: 4 generations back to K001085 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093757: MD300C1 Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 5.

## Most influential descendants
- K161938: Fingertip Pulse Oximeter (2017), 0 descendants of its own

## Indications for use
The pulse oximeter (BM1000A & BM2000A) is designed for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment. This medical device can be reused. Not for continuously monitoring.

Source page: https://510kreport.com/device/K142687
Methodology: https://510kreport.com/methodology