Cleared Traditional

K112131 - NEODYNE DRESSING

K112131 is an FDA 510(k) clearance for NEODYNE DRESSING, manufactured by Neodyne Biosciences, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K112131 · Neodyne Biosciences, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
65d
Days
Class 1
Risk

K112131 is an FDA 510(k) clearance for the NEODYNE DRESSING. Classified as Elastomer, Silicone, For Scar Management (product code MDA), Class I - General Controls.

Submitted by Neodyne Biosciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on September 29, 2011 after a review of 65 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4025 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K112131

510(k) Number K112131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2011
Decision Date September 29, 2011
Days to Decision 65 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
50d faster than avg
Panel avg: 115d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

MDA Device Classification - Class 1, General Controls

Product Code MDA Elastomer, Silicone, For Scar Management
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4025
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDA Elastomer, Silicone, For Scar Management

All 79
Devices cleared under the same product code (MDA) and FDA review panel - the closest regulatory comparables to K112131.
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K040307 · Hanson Medical, Inc. · Aug 2004
CURAD SCAR THERAPY
K024057 · Beiersdorf, Inc. · Jun 2003
K112131 · NEODYNE DRESSING
Download PDF FDA Summary Neodyne Biosciences, …