Cleared Traditional

K980117 - NUVO BARRIER FILM

K980117 is an FDA 510(k) clearance for NUVO BARRIER FILM, manufactured by Biomedical Development Co.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 339-day FDA review.

K980117 · Biomedical Development Co. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
339d
Days
Class 1
Risk

K980117 is an FDA 510(k) clearance for the NUVO BARRIER FILM. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Biomedical Development Co. (Fort Worth, US). The FDA issued a Cleared decision on December 18, 1998 after a review of 339 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 880.5090 - 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.

View all Biomedical Development Co. devices

FDA 510(k) Submission Details - K980117

510(k) Number K980117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1998
Decision Date December 18, 1998
Days to Decision 339 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 115d · This submission: 339d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
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 - KMF Bandage, Liquid

All 145
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K980117.
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
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COMFEEL SEASORB DRESSING
K983519 · Coloplast Corp. · Dec 1998
MODIFICATION TO SKVEKPATCH
K984177 · Marine Polymer Technologies, Inc. · Dec 1998
ALGISITE M
K983210 · Smith & Nephew, Inc. · Dec 1998
ACTICOAT COMPOSITE WOUND DRESSING, ACTICOAT COMPOSITE WOUND DRESSING-ADHESIVE
K983833 · Westaim Biomedical, Inc. · Dec 1998