Cleared Traditional

HEMOR-RITE CRYOTHERAPHY (K042564) - FDA 510(k) Clearance

K042564 · Fama Holdings International Corp · Gastroenterology & Urology device
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Sep 2005
Decision
374d
Days
-
Risk

K042564 is an FDA 510(k) clearance for the HEMOR-RITE CRYOTHERAPHY. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Fama Holdings International Corp (Parkland, US). The FDA issued a Cleared decision on September 30, 2005 after a review of 374 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 K042564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date September 30, 2005
Days to Decision 374 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
244d slower than avg
Panel avg: 130d · This submission: 374d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -