Cleared Traditional

K121361 - CURALINE POLYURETHANE FOAM AWC DRESSING

K121361 · Curaline, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2012
Decision
207d
Days
-
Risk

K121361 is an FDA 510(k) clearance for the CURALINE POLYURETHANE FOAM AWC DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Curaline, Inc. (Mequon, US). The FDA issued a Cleared decision on November 30, 2012 after a review of 207 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K121361

510(k) Number K121361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2012
Decision Date November 30, 2012
Days to Decision 207 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
92d slower than avg
Panel avg: 115d · This submission: 207d
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K121361.
VASHE SKIN AND WOUND HYDROGEL
K123071 · Puricore, Inc. · Jan 2013
NIXALL TM WOUND AND SKIN CARE
K113693 · Seriously Clean, Ltd. · Dec 2012
L.A.M. IMP WOUND GEL
K123113 · Glycobiosciences, Inc. · Dec 2012
HYLATOPICPLUS LOTION
K121559 · Precision Dermatology Incorporated · Nov 2012
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
K120930 · Medtrade Products , Ltd. · Oct 2012
BENEHOLD CHG TRANSPARENT FILM DRESSING (10X12CM) (8.5X12CM) (6.5X7 CM)
K113836 · Avery Dennison Belgie Bvba · Sep 2012
K121361 · CURALINE POLYURETHANE FOAM AWC DRESSING
Download PDF FDA Summary Curaline, Inc.