Cleared Traditional

KLEENIT BY QMED (K843559) - FDA 510(k) Clearance

K843559 · Qmed, Inc. · General & Plastic Surgery device
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Oct 1984
Decision
44d
Days
-
Risk

K843559 is an FDA 510(k) clearance for the KLEENIT BY QMED.

Submitted by Qmed, Inc. (Louisville, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 44 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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 Qmed, Inc. devices

Submission Details

510(k) Number K843559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1984
Decision Date October 24, 1984
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -