# K091908: M3 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Ltd.
- Decided: Jul 10, 2009 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K931968 (1993). 6 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072131: M3 Monitor, Spectrum Medical, Ltd. (2007) Summary page 1.
- K940651: Sarns Ultrasonic Air Sensor, 3M Health Care, Sarns (1994) Summary page 1.

## Most influential descendants
- K110957: M4 Monitor (2011), 4 descendants of its own
- K173591: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas (2018), 3 descendants of its own
- K181942: Quantum Ventilation Module (2018), 2 descendants of its own
- K202733: Quantum Ventilation Module (2020), 1 descendant of its own
- K210669: Quantum Mini Ventilation Module (2021), 0 descendants of its own

## Recalls of this device
- Apr 13, 2017 · Class II · Z-2056-2017: Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.

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

Source page: https://510kreport.com/device/K091908
Methodology: https://510kreport.com/methodology