Cleared Traditional

HEMOREST(TM) (K864470) - FDA 510(k) Clearance

K864470 · Health Aid Products · Gastroenterology & Urology device
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Jun 1987
Decision
223d
Days
-
Risk

K864470 is an FDA 510(k) clearance for the HEMOREST(TM). Classified as Cushion, Hemorrhoid (product code LRL).

Submitted by Health Aid Products (Miami Lakes, US). The FDA issued a Cleared decision on June 23, 1987 after a review of 223 days - an extended review cycle.

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. Standard predicate reliance. 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 K864470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date June 23, 1987
Days to Decision 223 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
93d slower than avg
Panel avg: 130d · This submission: 223d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRL Cushion, Hemorrhoid
Device Class -