# K131762: Handheld Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Biolight Meditech Co., Ltd.
- Decided: Jun 6, 2014 after 354 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- 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). 91 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000, Guangdong Biolight Meditech Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K150869: Checkme Pro Health Monitor (2015), 5 descendants of its own
- K191088: Checkme O2 Pulse Oximeter (2019), 2 descendants of its own
- K242876: Pulse Oximeter ( PO2, PO2A, PO2B) (2025), 0 descendants of its own
- K232111: NeoBeat, NeoBeat Mini (2024), 0 descendants of its own
- K213515: WesperO2 (2022), 0 descendants of its own

## Indications for use
M800 handheld monitor is intended for continuously monitoring or spot checking of SpO2, PR, ECG and HR 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/K131762
Methodology: https://510kreport.com/methodology