Cleared Traditional

KALTOSTAT WOUND PACKING (K892868) - FDA 510(k) Clearance

K892868 · Calgon Vestal Div. · General & Plastic Surgery device
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Jul 1989
Decision
86d
Days
-
Risk

K892868 is an FDA 510(k) clearance for the KALTOSTAT WOUND PACKING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Calgon Vestal Div. (St. Louis, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 86 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

Submission Details

510(k) Number K892868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1989
Decision Date July 14, 1989
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K892868.
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
K042164 · Medline Industries, Inc. · Jun 2005
ACTICOAT MOISTURE CONTROL DRESSING
K050030 · Smith & Nephew, Inc. · Apr 2005
3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
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