# K062468: Spectrum M2 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Llp
- Decided: Sep 13, 2006 after 20 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: 1 generation back to K931968 (1993). 1 ancestor in all.
15 later devices descend from it; 1 cites 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.

## Most influential descendants
- K071725: M2 Monitor (2007), 14 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K062468
Methodology: https://510kreport.com/methodology