# K101694: Handheld Pulse Oximeter Model M800

- Pathway: 510(k) (Special)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Sep 8, 2010 after 84 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 1.

## Indications for use
M800 Handheld Pulse Oximeter is indicated for spot checking of functional arterial oxygen saturation (SPO 2) and pulse rate of adult, pediatric and neonatal patients in hospital, hospital type facilities as well as in the home care environment.

Source page: https://510kreport.com/device/K101694
Methodology: https://510kreport.com/methodology