Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

°M Warmer System with °M Station

K-Number: K260988 · 2026-04-24

ApplicantMequ A/S
Decision Date2026-04-24
Product CodeLGZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

°M Warmer System with °M Station is the device name listed in this FDA 510(k) record. The listed applicant is Mequ A/S. It received FDA 510(k) clearance on 2026-04-24 under 510(k) number K260988. The device is classified under product code LGZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the °M Warmer System with °M Station?

°M Warmer System with °M Station is a medical device that received FDA 510(k) clearance on 2026-04-24. The listed applicant is Mequ A/S. The 510(k) number is K260988.

When did °M Warmer System with °M Station receive FDA 510(k) clearance?

°M Warmer System with °M Station received FDA 510(k) clearance on 2026-04-24, under 510(k) number K260988.

Who is the listed applicant for °M Warmer System with °M Station?

The FDA 510(k) record lists Mequ A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for °M Warmer System with °M Station?

The FDA product code for °M Warmer System with °M Station is LGZ.

Other records listing Mequ A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232107°M Warmer System

Related Devices (Code: LGZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252636Fluido Compact SystemThe Surgical Company International B.V.K251733Fluido® AirGuard SystemThe Surgical Company International BV (As Tsc Life)K232107°M Warmer SystemMequ A/SK211618Fluido Compact Blood and Fluid Warming SystemThe Surgical Company International B.V.K211800Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid WarmerQuality IN Flow , Ltd.K202461ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion SystemSmisson-Cartledge Biomedical, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑