# K112804: Fingertip Pulse Oximeter

- Pathway: 510(k) (Special)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Jan 27, 2012 after 122 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). 107 ancestors in all.
No later device cites it as a predicate yet.
0 of 108 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 2.

## Indications for use
The Fingertip Pulse Oximeters M7OA, M7OB, M70C and M7OD, are intended to measure functional arterial oxygen saturation (SpOz) and pulse rate of adult patients in hospital, hospital type facilities as well as in the home care environment. The oximeters are not suitable to monitor patient continuously for long term.

Source page: https://510kreport.com/device/K112804
Methodology: https://510kreport.com/methodology