Cleared Traditional

THERMA-H (K905276) - FDA 510(k) Clearance

K905276 · Kure Swiss Medical AG Corp. · Gastroenterology & Urology device
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Nov 1991
Decision
349d
Days
-
Risk

K905276 is an FDA 510(k) clearance for the THERMA-H. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Kure Swiss Medical AG Corp. (Miami, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel. 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K905276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1990
Decision Date November 07, 1991
Days to Decision 349 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
219d slower than avg
Panel avg: 130d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -