Cleared Traditional

K032239 - THERA-CREAM

K032239 is the FDA 510(k) clearance for THERA-CREAM by Prizm Medical, Inc.. It is a Class 2 Neurology device (product code GYB) cleared through the Traditional 510(k) pathway after a 375-day FDA review.

K032239 · Prizm Medical, Inc. · Neurology device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
375d
Days
Class 2
Risk

K032239 is an FDA 510(k) clearance for the THERA-CREAM, MODEL TCT004. Classified as Media, Electroconductive (product code GYB), Class II - Special Controls.

Submitted by Prizm Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on July 30, 2004 after a review of 375 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1275 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Prizm Medical, Inc. devices

Submission Details

510(k) Number K032239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date July 30, 2004
Days to Decision 375 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
227d slower than avg
Panel avg: 148d · This submission: 375d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GYB Media, Electroconductive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1275
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 Neurology devices follow this clearance model.

Regulatory Peers - GYB Media, Electroconductive

All 14
Devices cleared under the same product code (GYB) and FDA review panel - the closest regulatory comparables to K032239.
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