Cleared Traditional

ZEROID HEMORRHOIDAL DEVICE (K944874) - FDA 510(k) Clearance

K944874 · Medical Appliance Research Corp. · Gastroenterology & Urology device
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Aug 1995
Decision
308d
Days
-
Risk

K944874 is an FDA 510(k) clearance for the ZEROID HEMORRHOIDAL DEVICE. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by Medical Appliance Research Corp. (North Miami Beach, US). The FDA issued a Cleared decision on August 7, 1995 after a review of 308 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 K944874 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date August 07, 1995
Days to Decision 308 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 130d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -