Cleared Traditional

K871327 - D.R.P. THREE STEP WOUND DRESSING

K871327 · Bioderm, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1987
Decision
220d
Days
-
Risk

K871327 is an FDA 510(k) clearance for the D.R.P. THREE STEP WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Bioderm, Inc. (Wheaton, US). The FDA issued a Cleared decision on November 9, 1987 after a review of 220 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 Bioderm, Inc. devices

FDA 510(k) Submission Details - K871327

510(k) Number K871327 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 03, 1987
Decision Date November 09, 1987
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
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 227
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K871327.
AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA.
K881048 · Smith & Nephew, Inc. · Mar 1988
DERMATOLOGICAL PATCH
K872926 · Convatec, A Division of E.R. Squibb & Sons · Feb 1988
COMFEEL ULCUS ULCER CARE SYSTEM
K873669 · Coloplast A/S · Nov 1987
INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING
K872624 · Smith & Nephew, Inc. · Jul 1987
CUTINOVA(R) PLUS FOAM GELFILM
K864913 · Beiersdorf, Inc. · Jul 1987
AMERICAN PHARMASEAL WOUND DRESSING
K871770 · American Pharmaseal Div. Ahsc · Jun 1987