Cleared Traditional

K032239 - THERA-CREAM, MODEL TCT004

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

K032239 · Prizm Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K032239

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.

GYB Device Classification - Class 2, Special Controls

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 38
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K964737 · D.O. Weaver Co. · Mar 1997