Cleared Traditional

K902345 - CARRINGTON WOUND DRESSING

K902345 · Carrington Laboratories, Inc. · General & Plastic Surgery device
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Jun 1990
Decision
13d
Days
-
Risk

K902345 is an FDA 510(k) clearance for the CARRINGTON WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Carrington Laboratories, Inc. (Dallas, US). The FDA issued a Cleared decision on June 7, 1990 after a review of 13 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 Carrington Laboratories, Inc. devices

FDA 510(k) Submission Details - K902345

510(k) Number K902345 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 25, 1990
Decision Date June 07, 1990
Days to Decision 13 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
102d faster than avg
Panel avg: 115d · This submission: 13d
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 280
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K902345.
DERMAGRAN WOUND DRESSING
K924754 · Derma Sciences, Inc. · May 1993
INCARE HOT/ICE ABSORBENT INTERFACE
K913035 · Hollister, Inc. · Sep 1991
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
K904852 · Convatec, A Division of E.R. Squibb & Sons · Jan 1991
WOUND TREATMENT KIT
K901109 · Orion Life Systems, Inc. · Jun 1990
SILASTIC SOFT SHEETING
K894226 · Dow Corning Wright · Jan 1990
KALTOCARB WOUND DRESSING
K894347 · Calgon Vestal Div. · Aug 1989