# K071725: M2 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: Jul 11, 2007 after 16 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: 2 generations back to K931968 (1993). 2 ancestors in all.
14 later devices descend from it; 2 cite it directly.
2 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931968: Cdi 100 Extracorporeal Hematocrit/Oxygen Saturatio, 3M Health Care, Ltd. (1993) Summary page 1.
- K062468: Spectrum M2 Monitor, Spectrum Medical, Llp (2006) Summary page 1.

## Most influential descendants
- K072131: M3 Monitor (2007), 10 descendants of its own
- 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

## Indications for use
The M2 Monitor is intended as a device for the non-invasive continuous monitoring of oxygen saturation, hematocrit and haemoglobin concentration of the blood in an extracorporeal circuit. The device provides monitoring information to trained clinicians and can be configured by them to set parameter specific alarm levels.

Source page: https://510kreport.com/device/K071725
Methodology: https://510kreport.com/methodology