# K151287: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Jan 6, 2016 after 237 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: 15 generations back to K941811 (1994). 109 ancestors in all.
No later device cites it as a predicate yet.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081712: Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700, Guangdong Biolight Meditech Co., Ltd. (2008) Summary page 5.
- K141128: Fingertip Pulse Oximeter, Beijing Choice Electronic Technololgy Co., Ltd. (2014) Summary page 5.

## Indications for use
The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.

Source page: https://510kreport.com/device/K151287
Methodology: https://510kreport.com/methodology