°M Warmer System with °M Station— 510(k) K260988

Name: FDA 510(k) clearance K260988
Creator: U.S. Food and Drug Administration
Published: 2026-04-24

Substantially Equivalent

Mequ A/S

FDA 510(k) clearance K260988 for °M Warmer System with °M Station, Substantially Equivalent on 2026-04-24. Applicant: Mequ A/S. Device class: 2.

Summary

Mequ A/S's °M Warmer System with °M Station is filed under product code LGZ (Warmer, Thermal, Infusion Fluid). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 880.5725. General Hospital is both the classification panel and the review panel. It came in as a Special 510(k).

Mequ filed from Copenhagen/Kobenhavn, Denmark. The record shows 30 calendar days from receipt to decision (March 25 to April 24, 2026).

Clearance details

Applicant: Mequ A/S
Product code: Product code LGZ
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2026-03-25
Decision date: 2026-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Copenhagen/Kobenhavn, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code LGZ

view all

K262532 — NORMOFLO Irrigation Fluid Warming Sets and Accessories (IR-601, IR-501, IR-61, PL-61)2026-09-18
K252636 — Fluido Compact System2025-11-18
K251733 — Fluido® AirGuard System2025-09-04
K232107 — °M Warmer System2024-05-31
K211618 — Fluido Compact Blood and Fluid Warming System2023-06-05

Adverse events under product code LGZ

product code LGZ

Death: 16
Malfunction: 5,916
Other: 1
Total: 5,933

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.