Cleared Traditional

K872101 - BIOFILM TRANS. POUCH ULCER & WOUND DRESSING

K872101 is an FDA 510(k) clearance for BIOFILM TRANS. POUCH ULCER & WOUND DRESSING, manufactured by The Bfgoodrich Co.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K872101 · The Bfgoodrich Co. · General & Plastic Surgery device
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Jun 1987
Decision
29d
Days
Class 1
Risk

K872101 is an FDA 510(k) clearance for the BIOFILM TRANS. POUCH ULCER & WOUND DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by The Bfgoodrich Co. (Brecksville, US). The FDA issued a Cleared decision on June 30, 1987 after a review of 29 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4020 - 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: 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 The Bfgoodrich Co. devices

FDA 510(k) Submission Details - K872101

510(k) Number K872101 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 01, 1987
Decision Date June 30, 1987
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

NAD Device Classification - Class 1, General Controls

Product Code NAD Dressing, Wound, Occlusive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4020
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 - NAD Dressing, Wound, Occlusive

All 56
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K872101.
TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING
K872988 · Smith & Nephew, Inc. · Sep 1987
STRETCH GAUZE BANDAGES
K872875 · Abco Dealers, Inc. · Sep 1987
JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING
K872982 · Johnson & Johnson Professionals, Inc. · Aug 1987
ALLEVYN HYDROPHILIC POLYURETHANE DRESSING
K871166 · Smith & Nephew, Inc. · Jun 1987
BANDAGES CATALOG NUMBER: 101 TO 220
K871495 · I M, Inc. · May 1987
BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE)
K870185 · Fraass Survival Systems, Inc. · Feb 1987