Cleared Traditional

K062644 - FLEXWARMER, MODELS KZ-1 AND KZ-2

K062644 is an FDA 510(k) clearance for FLEXWARMER, manufactured by Merlyn Associates, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 370-day FDA review.

K062644 · Merlyn Associates, Inc. · General Hospital
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Sep 2007
Decision
370d
Days
Class 2
Risk

K062644 is an FDA 510(k) clearance for the FLEXWARMER, MODELS KZ-1 AND KZ-2. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Merlyn Associates, Inc. (Tustin, US). The FDA issued a Cleared decision on September 11, 2007 after a review of 370 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 - K062644

510(k) Number K062644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2006
Decision Date September 11, 2007
Days to Decision 370 days
Submission Type Traditional
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
241d slower than avg
Panel avg: 129d · This submission: 370d
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 K062644.
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
K082217 · Arizant Healthcare, Inc. · Oct 2008
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
K072080 · Smiths Medical Asd, Inc. · Jun 2008
THERMOSTAT 900 ADMINISTRATION SET, MODEL ASH 100, 200 AND 300
K073363 · Paladin Biomedical Corporation · Mar 2008
HYPERTHERMIA PUMP
K070654 · Belmont Instrument Corp. · Jun 2007
SOFT SACK IV FLUID WARMER, THE FLOORMOUNT IV FLUID WARMER, THE PAK 2 IV WARMER AND THE THERMAL SAC PRESSURE INFUSER
K060851 · The Smithworks Company · Dec 2006
SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200
K052055 · Smisson-Cartledge Biomedical, LLC · Oct 2006
K062644 · FLEXWARMER, MODELS KZ-1 AND KZ-2
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