Cleared Traditional

K023653 - MAXONE IV FLUID/BLOOD WARMER, MODEL 102

K023653 is an FDA 510(k) clearance for MAXONE IV FLUID/BLOOD WARMER, 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 79-day FDA review.

K023653 · Automatic Medical Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
79d
Days
Class 2
Risk

K023653 is an FDA 510(k) clearance for the MAXONE IV FLUID/BLOOD WARMER, MODEL 102. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Automatic Medical Technologies, Inc. (Santa Ana, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 79 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K023653

510(k) Number K023653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2002
Decision Date January 17, 2003
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 K023653.
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · Belmont Instrument Corp. · Sep 2003
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712
K031390 · Minimed, Inc. · Jul 2003
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
K024373 · Elltec Co., Ltd. · Jan 2003
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
K023653 · MAXONE IV FLUID/BLOOD WARMER, MODEL 102
Download PDF FDA Summary Automatic Medical Tec…