Cleared Traditional

K941790 - PRO-TECT SAFETY DRESSING

K941790 · Pro-Tect Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K941790

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.

MGP Device Classification - Class 0,

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

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 59
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K941790.
CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING
K946338 · Certified Safety Mfg., Inc. · Mar 1995
CONMED VENI-GARD(TM I.V. DRESSING-PRODUCT LINE EXTENSION AND MODIFICATIONS
K950065 · Conmedcorp · Mar 1995
CUTIPLAST STERIL
K943363 · Beiersdorf, Inc. · Mar 1995
CUSH ISLAND DRESSING
K943424 · Cush Medical Products · Oct 1994
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · The Kendal Co. · Jul 1994
CUTIFILM(R) FILM
K926399 · Beiersdorf, Inc. · Nov 1993