Cleared Special

K090089 - BELMONT HYPERTHERMIA PUMP

K090089 is an FDA 510(k) clearance for BELMONT HYPERTHERMIA PUMP, manufactured by Belmont Instrument Corp.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Special 510(k) pathway after a 29-day FDA review.

K090089 · Belmont Instrument Corp. · General Hospital
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Feb 2009
Decision
29d
Days
Class 2
Risk

K090089 is an FDA 510(k) clearance for the BELMONT HYPERTHERMIA PUMP. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Belmont Instrument Corp. (Billerica, US). The FDA issued a Cleared decision on February 12, 2009 after a review of 29 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 - K090089

510(k) Number K090089 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2009
Decision Date February 12, 2009
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 72
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K090089.
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V
K091336 · Enthermics Medical Systems, Inc. · May 2010
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE
K092366 · Thermal Therapeutic Systems, Inc. · Mar 2010
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
ASTOFLO PLUS
K082765 · Stihler Electronic GmbH · Dec 2008
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
K090089 · BELMONT HYPERTHERMIA PUMP
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