Cleared Traditional

DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414 (K012816) - FDA 510(k) Clearance

K012816 · Dynarex Corp. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Oct 2002
Decision
421d
Days
-
Risk

K012816 is an FDA 510(k) clearance for the DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 3414. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Dynarex Corp. (Maineville, US). The FDA issued a Cleared decision on October 17, 2002 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Dynarex Corp. devices

Submission Details

510(k) Number K012816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2001
Decision Date October 17, 2002
Days to Decision 421 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
306d slower than avg
Panel avg: 115d · This submission: 421d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K012816.
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
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3M TEGADERM SILVER
K040890 · 3M Company · Nov 2004
TEGASORB(TM) ULCER DRESSING, #90-XXX
K891288 · 3M Company · Jun 1989
PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH
K885045 · Baxter Healthcare Corp · Mar 1989
PHARMASEAL STERILE WOUND CARE DRESSING
K884397 · Baxter Healthcare Corp · Dec 1988