Cleared Traditional

K894347 - KALTOCARB WOUND DRESSING

K894347 · Calgon Vestal Div. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
40d
Days
-
Risk

K894347 is an FDA 510(k) clearance for the KALTOCARB WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on August 23, 1989 after a review of 40 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 Calgon Vestal Div. devices

FDA 510(k) Submission Details - K894347

510(k) Number K894347 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date August 23, 1989
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
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 257
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K894347.
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
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989
CUTINOVA(R) PLUS ON VASCULAR STASIS ULCERS
K885279 · Beiersdorf, Inc. · Jun 1989
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989