Cleared Traditional

MOIST HEAT PAD (K924799) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924799 · Conair Corp. · Physical Medicine device
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Oct 1993
Decision
383d
Days
Class 2
Risk

K924799 is an FDA 510(k) clearance for the MOIST HEAT PAD. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Conair Corp. (Stamford, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5740 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Conair Corp. devices

Submission Details

510(k) Number K924799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1992
Decision Date October 12, 1993
Days to Decision 383 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
268d slower than avg
Panel avg: 115d · This submission: 383d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRT Pad, Heating, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5740
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 Physical Medicine devices follow this clearance model.