Cleared Traditional

K002409 - MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER

K002409 is an FDA 510(k) clearance for MAXONE, manufactured by Automatic Medical Technologies, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K002409 · Automatic Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K002409

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
Combination Product No
PCCP Authorized No
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.

LGZ Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K002409.
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc. · Oct 2001
ANIMEC, MODELS AM-2S-4 AND AM-2S-5
K012906 · Elltec Co., Ltd. · Oct 2001
TEMP 3
K012276 · Medical Solutions, Inc. · Aug 2001
HOTLINE 2 FLUID WARMER
K001764 · Sims Level 1, Inc. · Aug 2000
TEMPO III
K981509 · Medical Products, Inc. · Jul 1998
TEMPO AND TEMP H20
K973748 · Smith · Mar 1998
K002409 · MAXONE, BLOOD, BLOOD PRODUCTS AND IV FLUID WARMER
Download PDF FDA Summary Automatic Medical Tec…