Cleared Traditional

MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER (K002409) - FDA 510(k) Clearance

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

K002409 · Automatic Medical Technologies, Inc. · General Hospital
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Jun 2001
Decision
325d
Days
Class 2
Risk

K002409 is an FDA 510(k) clearance for the MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Automatic Medical Technologies, Inc. (Los Angeles, US). The FDA issued a Cleared decision on June 28, 2001 after a review of 325 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 Automatic Medical Technologies, Inc. devices

Submission Details

510(k) Number K002409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2000
Decision Date June 28, 2001
Days to Decision 325 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
196d slower than avg
Panel avg: 129d · This submission: 325d
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 K002409.
°M Warmer System with °M Station
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°M Warmer System
K232107 · Mequ A/S · May 2024
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