Cleared Traditional

MOIST HEAT PACK (K803177) - FDA 510(k) Clearance

Class I Physical Medicine device.

K803177 · Duro-Med Ind., Inc. · Physical Medicine device
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Dec 1980
Decision
15d
Days
Class 1
Risk

K803177 is an FDA 510(k) clearance for the MOIST HEAT PACK. Classified as Pack, Heat, Moist (product code IMA), Class I - General Controls.

Submitted by Duro-Med Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5730 - 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 Duro-Med Ind., Inc. devices

Submission Details

510(k) Number K803177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1980
Decision Date December 31, 1980
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IMA Pack, Heat, Moist
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5730
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.