Cleared Traditional

K854850 - FALKON STRETCH-STERILE

K854850 is an FDA 510(k) clearance for FALKON STRETCH-STERILE, manufactured by G.B.F. Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code NAD cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K854850 · G.B.F. Industries, Inc. · General & Plastic Surgery device
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Jan 1986
Decision
40d
Days
Class 1
Risk

K854850 is an FDA 510(k) clearance for the FALKON STRETCH-STERILE. Classified as Dressing, Wound, Occlusive (product code NAD), Class I - General Controls.

Submitted by G.B.F. Industries, Inc. (New York, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 40 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 G.B.F. Industries, Inc. devices

FDA 510(k) Submission Details - K854850

510(k) Number K854850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1985
Decision Date January 13, 1986
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
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 55
Devices cleared under the same product code (NAD) and FDA review panel - the closest regulatory comparables to K854850.
EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES
K864011 · Fraass Survival Systems, Inc. · Nov 1986
WOUND MANAGER(TM) - STERILE
K862935 · Convatec, A Division of E.R. Squibb & Sons · Aug 1986
LYOFOAM WOUND DRESSINGS
K860085 · Acme United Corp. · Jun 1986
OPSITE WOUND DRESSING
K852211 · Smith & Nephew, Inc. · Jul 1985
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851382 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985
BLISTERFILM TRANSPARENT DRESSING
K851383 · Chesebrough-Pond'S U.S.A. Co. · Jul 1985