Cleared Traditional

ROUND WASHBASIN & RECTANGLE WASHBASIN (K791348) - FDA 510(k) Clearance

K791348 · General Clinical Plastics Corp. · General Hospital
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Sep 1979
Decision
67d
Days
-
Risk

K791348 is an FDA 510(k) clearance for the ROUND WASHBASIN & RECTANGLE WASHBASIN.

Submitted by General Clinical Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1979 after a review of 67 days - a notably fast clearance cycle.

This device falls under the General Hospital 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 General Clinical Plastics Corp. devices

Submission Details

510(k) Number K791348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1979
Decision Date September 17, 1979
Days to Decision 67 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 129d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -