Cleared Traditional

K112666 - SALINE WOUND WASH

K112666 · Nanoplas, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 648
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K112666.
MANUKA IG
K120976 · Links Medical Products, Inc. · May 2012
MANUKA FILL
K121227 · Links Medical Products, Inc. · May 2012
IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
K112549 · Covalontechnologies, Inc. · May 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
DEXERYL CREAM
K113807 · Pierre Fabre Medical Devices · Mar 2012
K112666 · SALINE WOUND WASH
Download PDF FDA Summary Nanoplas, Inc.