# K072131: M3 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: Aug 17, 2007 after 15 days
- Product code: DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931968 (1993). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
2 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071725: M2 Monitor, Spectrum Medical, Ltd. (2007) Summary page 1.
- K872048: Transonic Flowmeter, Transonic Systems, Inc. (1988) Summary page 1.

## Most influential descendants
- K091908: M3 Monitor (2009), 5 descendants of its own
- K110957: M4 Monitor (2011), 4 descendants of its own
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), 3 descendants of its own
- K090147: Blood Monitoring Unit, Model Bmu 40 (2009), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own

## Indications for use
The M3 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration and the flow of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to alarm to set parameter specific alarms.

Source page: https://510kreport.com/device/K072131
Methodology: https://510kreport.com/methodology