# K081712: Fingertip Pulse Oximeter, Model M70, and Handheld Pulse Oximeter, Model M700

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Sep 12, 2008 after 87 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: 14 generations back to K941811 (1994). 106 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 110 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070371: Fingertip Pulse Oximeter MD300C, Beijing Choice Electronic Technololgy Co., Ltd. (2007) Summary page 2.
- K072581: PM-60 Pulse Oximeter, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2008) Summary page 2.

## Most influential descendants
- K151287: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (2016), 0 descendants of its own
- K112804: Fingertip Pulse Oximeter (2012), 0 descendants of its own
- K101694: Handheld Pulse Oximeter Model M800 (2010), 0 descendants of its own

## Indications for use
The M70 fingertip pulse oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult 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. The M700 handheld pulse oximeter is indicated for spot checking of functional arterial oxygen saturation (SP0 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/K081712
Methodology: https://510kreport.com/methodology