Cleared Traditional

RELIEF (K812567) - FDA 510(k) Clearance

K812567 · American Pharmaceutical Co., Inc. · Gastroenterology & Urology device
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Nov 1981
Decision
62d
Days
-
Risk

K812567 is an FDA 510(k) clearance for the RELIEF. Classified as Device, Thermal, Hemorrhoids (product code LKX).

Submitted by American Pharmaceutical Co., Inc. (Walker, US). The FDA issued a Cleared decision on November 10, 1981 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Pharmaceutical Co., Inc. devices

Submission Details

510(k) Number K812567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1981
Decision Date November 10, 1981
Days to Decision 62 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
68d faster than avg
Panel avg: 130d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LKX Device, Thermal, Hemorrhoids
Device Class -