Cleared Traditional

K892364 - KALTOSTAT(TM) WOUND DRESSING

K892364 · Calgon Vestal Div. · General & Plastic Surgery device
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Jun 1989
Decision
78d
Days
-
Risk

K892364 is an FDA 510(k) clearance for the KALTOSTAT(TM) 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 June 23, 1989 after a review of 78 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 - K892364

510(k) Number K892364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1989
Decision Date June 23, 1989
Days to Decision 78 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
37d faster than avg
Panel avg: 115d · This submission: 78d
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
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K892360 · Pfizer, Inc. · Jun 1989