Cleared Special

K152208 - The Belmont Hyperthermia Pump

K152208 is an FDA 510(k) clearance for The Belmont Hyperthermia Pump, manufactured by Belmont Instrument Corporation. The device is a Class 2 General Hospital device with product code LGZ cleared through the Special 510(k) pathway after a 26-day FDA review.

K152208 · Belmont Instrument Corporation · General Hospital
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Sep 2015
Decision
26d
Days
Class 2
Risk

K152208 is an FDA 510(k) clearance for the The Belmont Hyperthermia Pump. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Belmont Instrument Corporation (Billerica, US). The FDA issued a Cleared decision on September 2, 2015 after a review of 26 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.

View all Belmont Instrument Corporation devices

FDA 510(k) Submission Details - K152208

510(k) Number K152208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2015
Decision Date September 02, 2015
Days to Decision 26 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 129d · This submission: 26d
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 25
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K152208.
MAC Medical D-Series Blanket and Solution Warming Cabinets
K180842 · Mac Medical, Inc. · Mar 2019
Quantum Blood and IV Fluid Infusion Warmer
K181775 · Life Warmer, Inc. · Jan 2019
QiF Blood and Fluid Warmer
K180154 · Quality IN Flow , Ltd. · Apr 2018
BELMONT HYPERTHERMIA PUMP
K131519 · Belmont Instrument Corp. · Nov 2013
ENFLOW IV FLUID WARMER
K112902 · Vital Signs, Inc. · Mar 2012
AMSCO WARMING CABINET
K111870 · STERIS Corporation · Jul 2011