Cleared Special

K024373 - MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5

K024373 is an FDA 510(k) clearance for MODIFICATION TO ANIMEC, manufactured by Elltec Co., Ltd.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K024373 · Elltec Co., Ltd. · General Hospital
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Jan 2003
Decision
28d
Days
Class 2
Risk

K024373 is an FDA 510(k) clearance for the MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Elltec Co., Ltd. (Nagoya, JP). The FDA issued a Cleared decision on January 28, 2003 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K024373

510(k) Number K024373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2002
Decision Date January 28, 2003
Days to Decision 28 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K024373.
LARGE VOLUME FLUID RESERVOIR
K032778 · Belmont Instrument Corp. · Sep 2003
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
MAXONE IV FLUID/BLOOD WARMER, MODEL 102
K023653 · Automatic Medical Technologies, Inc. · 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
K024373 · MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
Download PDF Elltec Co., Ltd.