Cleared Traditional

K945830 - DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)

K945830 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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Jan 1995
Decision
43d
Days
-
Risk

K945830 is an FDA 510(k) clearance for the DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE). Classified as Gauze/sponge, Internal (product code EFQ).

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on January 11, 1995 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K945830

510(k) Number K945830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1994
Decision Date January 11, 1995
Days to Decision 43 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 115d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

EFQ Device Classification - Class 0,

Product Code EFQ Gauze/sponge, Internal
Device Class -

Regulatory Peers - EFQ Gauze/sponge, Internal

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Devices cleared under the same product code (EFQ) and FDA review panel - the closest regulatory comparables to K945830.
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K945019 · Clinical Resources, Inc. · Dec 1994
FLUFF GAUZE SPONGE
K945020 · Clinical Resources, Inc. · Dec 1994
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K945021 · Clinical Resources, Inc. · Dec 1994
K945830 · DUFLEX CONFORMING BANDAGE (STERILE/NON-STERILE)
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