Cleared Traditional

K896828 - BIOCLUSIVE(R) ABSORBENT DRESSING (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K896828 · Johnson & Johnson International · General & Plastic Surgery device
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Nov 1990
Decision
352d
Days
Class 1
Risk

K896828 is an FDA 510(k) clearance for the BIOCLUSIVE(R) ABSORBENT DRESSING. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Johnson & Johnson International (New Brunswick, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4018 - the FDA general and plastic surgery device framework. 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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K896828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date November 21, 1990
Days to Decision 352 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
238d slower than avg
Panel avg: 114d · This submission: 352d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KOZ Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4018
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.