Cleared Special

K100218 - BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM

K100218 · Coloplast A/S · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2010
Decision
22d
Days
-
Risk

K100218 is an FDA 510(k) clearance for the BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Coloplast A/S (Plymouth, US). The FDA issued a Cleared decision on February 17, 2010 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K100218

510(k) Number K100218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2010
Decision Date February 17, 2010
Days to Decision 22 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K100218.
MICROCYN SKIN AND WOUND HYDROGEL
K093585 · Oculus Innovative Sciences, Inc. · Mar 2010
VASHE WOUND CLEANSING SYSTEM
K093155 · Puricore, Inc. · Mar 2010
AFM ULTRA AG DRESSINGS
K093188 · Milliken & Co. · Feb 2010
TROPAZONE CR
K093544 · Midlothian Laboratories · Feb 2010
JALOSKIN
K092257 · Fidia Advanced Biopolymers Srl · Jan 2010
AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS
K091863 · Aubrey, Inc. · Jan 2010
K100218 · BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
Download PDF FDA Summary Coloplast A/S