Cleared Traditional

K933966 - SURE-ADAPT NON-ADHERING DRESSING

K933966 · Medtrax Industries, Inc. · General & Plastic Surgery device
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Oct 1993
Decision
73d
Days
-
Risk

K933966 is an FDA 510(k) clearance for the SURE-ADAPT NON-ADHERING DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medtrax Industries, Inc. (Longwood, US). The FDA issued a Cleared decision on October 28, 1993 after a review of 73 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 Medtrax Industries, Inc. devices

FDA 510(k) Submission Details - K933966

510(k) Number K933966 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received August 16, 1993
Decision Date October 28, 1993
Days to Decision 73 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
42d faster than avg
Panel avg: 115d · This submission: 73d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 594
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K933966.
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