Cleared Traditional

K232107 - °M Warmer System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K232107 · Mequ A/S · General Hospital
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May 2024
Decision
322d
Days
Class 2
Risk

K232107 is an FDA 510(k) clearance for the °M Warmer System. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Mequ A/S (Kobenhavn N, DK). The FDA issued a Cleared decision on May 31, 2024 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mequ A/S devices

Submission Details

510(k) Number K232107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2023
Decision Date May 31, 2024
Days to Decision 322 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 128d · This submission: 322d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 74
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K232107.
°M Warmer System with °M Station
K260988 · Mequ A/S · Apr 2026
Fluido Compact System
K252636 · The Surgical Company International B.V. · Nov 2025
Fluido® AirGuard System
K251733 · The Surgical Company International BV (As Tsc Life) · Sep 2025
Fluido Compact Blood and Fluid Warming System
K211618 · The Surgical Company International B.V. · Jun 2023
Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer
K211800 · Quality IN Flow , Ltd. · Dec 2022
ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System
K202461 · Smisson-Cartledge Biomedical, LLC · Aug 2022