Cleared Traditional

3 X 4 NON-ADHERENT PAD (K850595) - FDA 510(k) Clearance

K850595 · American White Cross, Inc. · General & Plastic Surgery device
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Mar 1985
Decision
24d
Days
-
Risk

K850595 is an FDA 510(k) clearance for the 3 X 4 NON-ADHERENT PAD.

Submitted by American White Cross, Inc. (Stamford, US). The FDA issued a Cleared decision on March 11, 1985 after a review of 24 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 American White Cross, Inc. devices

Submission Details

510(k) Number K850595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1985
Decision Date March 11, 1985
Days to Decision 24 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
91d faster than avg
Panel avg: 115d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -