Cleared Traditional

POLY-MEDICS HEAT PACK (K941245) - FDA 510(k) Clearance

Class I Physical Medicine device.

K941245 · Biomet, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
48d
Days
Class 1
Risk

K941245 is an FDA 510(k) clearance for the POLY-MEDICS HEAT PACK. Classified as Pack, Hot Or Cold, Disposable (product code IMD), Class I - General Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 2, 1994 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5710 - the FDA physical medicine 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 Biomet, Inc. devices

Submission Details

510(k) Number K941245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1994
Decision Date May 02, 1994
Days to Decision 48 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 115d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMD Pack, Hot Or Cold, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5710
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IMD Pack, Hot Or Cold, Disposable

All 81
Devices cleared under the same product code (IMD) and FDA review panel - the closest regulatory comparables to K941245.
InfaTherm Disposable Infant Warming Mattress
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K950680 · Baxter Healthcare Corp · Aug 1995
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ACE BRAND INSTANT COLD PACK
K820282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1982