Cleared Traditional

WEDGE PRESSURE DRESSING (K891189) - FDA 510(k) Clearance

K891189 · Durden Enterprises, Inc. · General & Plastic Surgery device
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May 1989
Decision
79d
Days
-
Risk

K891189 is an FDA 510(k) clearance for the WEDGE PRESSURE DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Durden Enterprises, Inc. (Auburn, US). The FDA issued a Cleared decision on May 24, 1989 after a review of 79 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 Durden Enterprises, Inc. devices

Submission Details

510(k) Number K891189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date May 24, 1989
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 163
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K891189.
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TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988
TEGASORB ULCER DRESSING #90-XXX
K872298 · 3M Company · Apr 1988