# K260988: °M Warmer System with °M Station

- Pathway: 510(k) (Special)
- Applicant: Mequ A/S
- Decided: Apr 24, 2026 after 30 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: 6 generations back to K770232 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232107: °M Warmer System, Mequ A/S (2024) Summary page 5.

## Indications for use
The °M Warmer System with °M Station 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 ambulances.

Source page: https://510kreport.com/device/K260988
Methodology: https://510kreport.com/methodology