Cleared Traditional

K031478 - MICROHEATER

K031478 is an FDA 510(k) clearance for MICROHEATER, manufactured by Belmont Instrument Corp.. The device is a Class 2 Hematology device with product code BSB cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K031478 · Belmont Instrument Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Jul 2003
Decision
51d
Days
Class 2
Risk

K031478 is an FDA 510(k) clearance for the MICROHEATER. 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 July 2, 2003 after a review of 51 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Belmont Instrument Corp. devices

FDA 510(k) Submission Details - K031478

510(k) Number K031478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2003
Decision Date July 02, 2003
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 10
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