Cleared Traditional

K812026 - K-MED SILICONE SUMP DRAIN (FDA 510(k) Clearance)

K812026 · K-Med, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1981
Decision
42d
Days
-
Risk

K812026 is an FDA 510(k) clearance for the K-MED SILICONE SUMP DRAIN.

Submitted by K-Med, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 42 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 K-Med, Inc. devices

Submission Details

510(k) Number K812026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1981
Decision Date August 31, 1981
Days to Decision 42 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
72d faster than avg
Panel avg: 114d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -