Cleared Traditional

K102945 - PEDIACYN ATOPIC DERMATITIS HYDROGEL

K102945 · Oculus Innovative Sciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
121d
Days
-
Risk

K102945 is an FDA 510(k) clearance for the PEDIACYN ATOPIC DERMATITIS HYDROGEL. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Oculus Innovative Sciences, Inc. (Petaluma, US). The FDA issued a Cleared decision on February 2, 2011 after a review of 121 days - within the typical 510(k) review window.

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.

View all Oculus Innovative Sciences, Inc. devices

FDA 510(k) Submission Details - K102945

510(k) Number K102945 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date February 02, 2011
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
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 239
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K102945.
DURAFIBER AG
K103793 · Smith & Nephew, Inc. · May 2011
PRONTOSAN WOUND IRRIGATION SOLUTION
K110744 · B.Braun Medical, Inc. · Apr 2011
MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY
K101793 · Derma Sciences, Inc. · Feb 2011
PRONTOSAN ANTIMICROBIAL WOUND GEL
K101882 · B.Braun Medical, Inc. · Nov 2010
BIATAIN AGFOAM DRESSINGS-NON-ADHESIV: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
K100218 · Coloplast A/S · Feb 2010
MEDLINE CURAD WOUND DRESSINGS
K093349 · Medline Industries, Inc. · Jan 2010