Cleared Traditional

K925630 - ELASTOPLAST HEAT PLASTER (FDA 510(k) Clearance)

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

K925630 · Beiersdorf, Inc. · Physical Medicine device
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Feb 1994
Decision
476d
Days
Class 2
Risk

K925630 is an FDA 510(k) clearance for the ELASTOPLAST HEAT PLASTER. Classified as Pad, Heating, Powered (product code IRT), Class II - Special Controls.

Submitted by Beiersdorf, Inc. (Norwalk, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 476 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Beiersdorf, Inc. devices

Submission Details

510(k) Number K925630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1992
Decision Date February 25, 1994
Days to Decision 476 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
361d slower than avg
Panel avg: 115d · This submission: 476d
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.