Cleared Special

K112639 - THE BELMONT BUDDY LITE FLUID WARMER

K112639 is an FDA 510(k) clearance for THE BELMONT BUDDY LITE FLUID WARMER, manufactured by Belmont Instrument Corp.. The device is a Class 2 Hematology device with product code BSB cleared through the Special 510(k) pathway after a 65-day FDA review.

K112639 · Belmont Instrument Corp. · Hematology device
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Nov 2011
Decision
65d
Days
Class 2
Risk

K112639 is an FDA 510(k) clearance for the THE BELMONT BUDDY LITE FLUID WARMER. Classified as Warmer, Blood, Non-electromagnetic Radiation (product code BSB), Class II - Special Controls.

Submitted by Belmont Instrument Corp. (Billerica, US). The FDA issued a Cleared decision on November 16, 2011 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9205 - the FDA hematology 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 - K112639

510(k) Number K112639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 2011
Decision Date November 16, 2011
Days to Decision 65 days
Submission Type Special
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 113d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

BSB Device Classification - Class 2, Special Controls

Product Code BSB Warmer, Blood, Non-electromagnetic Radiation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9205
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 Hematology devices follow this clearance model.

Regulatory Peers - BSB Warmer, Blood, Non-electromagnetic Radiation

All 12
Devices cleared under the same product code (BSB) and FDA review panel - the closest regulatory comparables to K112639.
THE BELMONT BUDDY LITE FLUID WARMER
K090508 · Belmont Instrument Corp. · Mar 2009
BELMONT BUDDY PLUS FLUID WARMER
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MICROHEATER
K031478 · Belmont Instrument Corp. · Jul 2003
ASTOFLO
K020060 · Nats Corp. · Mar 2002
MODIFICATION TO THERMAL ANGEL
K012031 · Estill Medical Technologies, Inc. · Jul 2001
K112639 · THE BELMONT BUDDY LITE FLUID WARMER
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