Cleared Traditional

K925630 - ELASTOPLAST HEAT PLASTER

K925630 is an FDA 510(k) clearance for ELASTOPLAST HEAT PLASTER, manufactured by Beiersdorf, Inc.. The device is a Class 2 Physical Medicine device with product code IRT cleared through the Traditional 510(k) pathway after a 476-day FDA review.

K925630 · Beiersdorf, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K925630

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
Combination Product No
PCCP Authorized No
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.

IRT Device Classification - Class 2, Special Controls

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.

Regulatory Peers - IRT Pad, Heating, Powered

All 10
Devices cleared under the same product code (IRT) and FDA review panel - the closest regulatory comparables to K925630.
bite away two
K250047 · mibeTec GmbH · Sep 2025
bite away neo
K220514 · mibeTec GmbH · Jun 2022
FEMININE HEAT WRAP
K924970 · Conair Corp. · Oct 1994
ARTHRITIC HEAT WRAP
K925820 · Conair Corp. · Feb 1994
MOIST HEAT PAD
K924799 · Conair Corp. · Oct 1993
MOSIST HEAT PAD WITH AUTOMATIC OFF
K924800 · Conair Corp. · Oct 1993