Cleared Traditional

K112666 - SALINE WOUND WASH

K112666 · Nanoplas, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
220d
Days
-
Risk

K112666 is an FDA 510(k) clearance for the SALINE WOUND WASH. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Nanoplas, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on April 20, 2012 after a review of 220 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.

View all Nanoplas, Inc. devices

FDA 510(k) Submission Details - K112666

510(k) Number K112666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2011
Decision Date April 20, 2012
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
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 264
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K112666.
3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING
K123679 · 3M Company · Feb 2013
LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
K120181 · Huizhou Foryou Medical Devices Co., Ltd. · Feb 2013
CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING
K120930 · Medtrade Products , Ltd. · Oct 2012
CURAD ANTIBACTERIAL BANDAGE
K113583 · Medline Industries, Inc. · Apr 2012
BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
K120828 · Coloplast A/S · Apr 2012
3M TEGADERM MATRIX DRESSING
K110457 · 3M Company · Dec 2011