Cleared Traditional

K892851 - ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER

K892851 · Johnson & Johnson Patient Care, Inc. · General & Plastic Surgery device
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Sep 1989
Decision
161d
Days
-
Risk

K892851 is an FDA 510(k) clearance for the ACTISORB* PLUS ACTIVATED CHARCOAL DRESS W/SILVER. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Johnson & Johnson Patient Care, Inc. (New Brunswick, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 161 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Johnson & Johnson Patient Care, Inc. devices

FDA 510(k) Submission Details - K892851

510(k) Number K892851 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 18, 1989
Decision Date September 26, 1989
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
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 591
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K892851.
DUODERM DRESSINGS, CGF DRESSINGS, PASTE FULL THICK
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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
INTRASITE* GEL (3) YEAR SHELF LIFE
K891870 · Smith & Nephew United, Inc. · Aug 1989
KALTOSTAT WOUND PACKING
K892868 · Calgon Vestal Div. · Jul 1989