Cleared Traditional

K875253 - BFGOODRICH BIOTHANE NON-ADHERENT DRESSING

K875253 is an FDA 510(k) clearance for BFGOODRICH BIOTHANE NON-ADHERENT 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 113-day FDA review.

K875253 · The Bfgoodrich Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1988
Decision
113d
Days
Class 1
Risk

K875253 is an FDA 510(k) clearance for the BFGOODRICH BIOTHANE NON-ADHERENT DRESSING. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by The Bfgoodrich Co. (Washington, US). The FDA issued a Cleared decision on April 13, 1988 after a review of 113 days - within the typical 510(k) review window.

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: 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 The Bfgoodrich Co. devices

FDA 510(k) Submission Details - K875253

510(k) Number K875253 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 22, 1987
Decision Date April 13, 1988
Days to Decision 113 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
2d faster than avg
Panel avg: 115d · This submission: 113d
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 K875253.
ALLEVYN TRACHEOSTOMY DRESSING
K890748 · Smith & Nephew United, Inc. · Mar 1989
TECNOL VARIABLE TENSION BANDAGE
K884440 · Tecnol New Jersey Wound Care, Inc. · Jan 1989
3M WOUND CONTACT MATERIAL, PRODUCT #563X
K881988 · 3M Company · Jun 1988
DUODERM(R) CGF
K881050 · Convatec, A Division of E.R. Squibb & Sons · Apr 1988
ENVICLUSIVE (TM)
K874554 · Marion Laboratories, Inc. · Mar 1988
PHARMACLUSIVE (TM)
K872573 · Pharmacia, Inc. · Feb 1988