Cleared Traditional

K052720 - MEDLINE IODOFORM PACKING STRIPS

K052720 · Medline Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
21d
Days
-
Risk

K052720 is an FDA 510(k) clearance for the MEDLINE IODOFORM PACKING STRIPS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on October 20, 2005 after a review of 21 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.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K052720

510(k) Number K052720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date October 20, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 115d · This submission: 21d
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 457
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K052720.
3M TEGADERM SILVER (AG) MESH
K053256 · 3M Company · Dec 2005
SILVERSEAL SILVERAID WITH X-STATIC
K050726 · Noble Fiber Technologies, Inc. · Dec 2005
FORTADERM ANTIMICROBIAL WOUND DRESSING
K051647 · Organogenesis, Inc. · Nov 2005
BIODERM SCIENCES WOUND CREAM
K042352 · Bioderm Sciences, Inc. · Oct 2005
MILLIKEN SILVER WOUND DRESSINGS
K051445 · Milliken Chemical · Aug 2005
BIODERM SCIENCES WOUND HEALING SPRAY
K042084 · Bioderm Sciences, Inc. · Jun 2005