Cleared Traditional

HEMAWAY SEAT (K072690) - FDA 510(k) Clearance

K072690 · Hemaway, LLC · Gastroenterology & Urology device
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Dec 2007
Decision
74d
Days
-
Risk

K072690 is an FDA 510(k) clearance for the HEMAWAY SEAT. Classified as Cushion, Hemorrhoid (product code LRL).

Submitted by Hemaway, LLC (Wilmington, US). The FDA issued a Cleared decision on December 7, 2007 after a review of 74 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 Hemaway, LLC devices

Submission Details

510(k) Number K072690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2007
Decision Date December 07, 2007
Days to Decision 74 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
56d faster than avg
Panel avg: 130d · This submission: 74d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRL Cushion, Hemorrhoid
Device Class -