Cleared Traditional

K872453 - DEBRISAN ABSORBENT PAD

K872453 is the FDA 510(k) clearance for DEBRISAN ABSORBENT PAD by Pharmacia, Inc.. It is a Class 1 General & Plastic Surgery device (product code KOZ) cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K872453 · Pharmacia, Inc. · General & Plastic Surgery device
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Jan 1988
Decision
205d
Days
Class 1
Risk

K872453 is an FDA 510(k) clearance for the DEBRISAN ABSORBENT PAD. Classified as Beads, Hydrophilic, For Wound Exudate Absorption (product code KOZ), Class I - General Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on January 14, 1988 after a review of 205 days - an extended review cycle.

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. 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K872453 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 23, 1987
Decision Date January 14, 1988
Days to Decision 205 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 115d · This submission: 205d
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.

Regulatory Peers - KOZ Beads, Hydrophilic, For Wound Exudate Absorption

All 8
Devices cleared under the same product code (KOZ) and FDA review panel - the closest regulatory comparables to K872453.
CUTINOVA HYDRO
K905688 · Beiersdorf, Inc. · Apr 1991
DERMASORB WOUND CONTACT LAYER DRESSING
K903645 · Convatec, A Division of E.R. Squibb & Sons · Nov 1990
ENVISAN PAD
K874552 · Marion Laboratories, Inc. · Jan 1988
ENVISAN PASTE
K874553 · Marion Laboratories, Inc. · Dec 1987
PHARMASEAL WOUND CARE DRESSING PAD
K870941 · American Pharmaseal Div. Ahsc · Mar 1987
COMFEEL POWDER
K834343 · Coloplast A/S · Nov 1984