Cleared Traditional

K072080 - NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,

K072080 is an FDA 510(k) clearance for NORMOFLO IRRIGATION FLUID WARMER, manufactured by Smiths Medical Asd, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K072080 · Smiths Medical Asd, Inc. · General Hospital
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Jun 2008
Decision
308d
Days
Class 2
Risk

K072080 is an FDA 510(k) clearance for the NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION .... Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Smiths Medical Asd, Inc. (Rockland, US). The FDA issued a Cleared decision on June 2, 2008 after a review of 308 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 Smiths Medical Asd, Inc. devices

FDA 510(k) Submission Details - K072080

510(k) Number K072080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2007
Decision Date June 02, 2008
Days to Decision 308 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
179d slower than avg
Panel avg: 129d · This submission: 308d
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 46
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K072080.
HYPOTHERMX INTRAVENOUS FLUID WARMER
K103801 · Emit Corporation · May 2011
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
BELMONT HYPERTHERMIA PUMP
K090089 · Belmont Instrument Corp. · Feb 2009
HYPERTHERMIA PUMP
K070654 · Belmont Instrument Corp. · Jun 2007
8NONE
K041839 · Medical Solutions, Inc. · Feb 2005
LARGE VOLUME FLUID RESERVOIR
K032778 · Belmont Instrument Corp. · Sep 2003