# K232107: °M Warmer System

- Pathway: 510(k) (Traditional)
- Applicant: Mequ A/S
- Decided: May 31, 2024 after 322 days
- Product code: LGZ (Warmer, Thermal, Infusion Fluid)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K770232 (1977). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112902: Enflow IV Fluid Warmer, Vital Signs, Inc. (2012) Summary page 5.

## Most influential descendants
- K260988: °M Warmer System with °M Station (2026), 0 descendants of its own

## Indications for use
The °M Warmer System is indicated for use to warm blood, blood products, colloids and crystalloid solutions prior to parenteral administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments to help prevent hypothermia. The field environment includes road, rotary and fixed-wing ambulances.

Source page: https://510kreport.com/device/K232107
Methodology: https://510kreport.com/methodology