# K110957: M4 Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Spectrum Medical, Llp
- Decided: May 31, 2011 after 56 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: 5 generations back to K931968 (1993). 11 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091908: M3 Monitor, Spectrum Medical, Ltd. (2009) Summary page 1.
- K972962: 3M Cdi Blood Parameter Monitoring System 500, 3M Company (1997) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The intended use of the M4 Monitor is for the non-invasive continuous monitoring of 02 saturation, hematocrit and haemoglobin concentration, blood flow, gaseous emboli, Temperature, P0 2, and PCO 2 , 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/K110957
Methodology: https://510kreport.com/methodology