Cleared Special

K131519 - BELMONT HYPERTHERMIA PUMP

K131519 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 162-day FDA review.

K131519 · Belmont Instrument Corp. · General Hospital
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Nov 2013
Decision
162d
Days
Class 2
Risk

K131519 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 November 6, 2013 after a review of 162 days - an extended review 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. Standard predicate reliance. 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 - K131519

510(k) Number K131519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2013
Decision Date November 06, 2013
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 K131519.
The Belmont Hyperthermia Pump
K152208 · Belmont Instrument Corporation · Sep 2015
Penguin In-Line Warmer
K150484 · Creche Innovations · Jul 2015
DC SERIES FLUID WARMING CABINET, DC SERIES FLUID WARMING CABINET
K132202 · Enthermics Medical Systems, Inc. · Dec 2013
NATUS WARMETTE BLANKET AND DUAL CABINETS
K132110 · Natus Nicolet Ireland, Ltd. · Oct 2013
ENFLOW IV FLUID WARMER INSULATED STRAP
K130867 · Vital Signs, Inc., A GE Healthcare Company · Jun 2013
ENTERAL NUTRITION WARMER
K122449 · Acacia, Inc. · Jun 2013
K131519 · BELMONT HYPERTHERMIA PUMP
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