Cleared Traditional

PRO-TECT SAFETY DRESSING (K941790) - FDA 510(k) Clearance

K941790 · Pro-Tect Medical Products, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 1995
Decision
276d
Days
-
Risk

K941790 is an FDA 510(k) clearance for the PRO-TECT SAFETY DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Pro-Tect Medical Products, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on January 12, 1995 after a review of 276 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pro-Tect Medical Products, Inc. devices

Submission Details

510(k) Number K941790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date January 12, 1995
Days to Decision 276 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 115d · This submission: 276d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -