Cleared Traditional

K130670 - HYDROFERA BLUE PU BACTERIOSTATIC DRESSING

K130670 · Hydrofera, LLC · General & Plastic Surgery device
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Jan 2014
Decision
296d
Days
-
Risk

K130670 is an FDA 510(k) clearance for the HYDROFERA BLUE PU BACTERIOSTATIC DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Hydrofera, LLC (Willimantic, US). The FDA issued a Cleared decision on January 2, 2014 after a review of 296 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 Hydrofera, LLC devices

FDA 510(k) Submission Details - K130670

510(k) Number K130670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2013
Decision Date January 02, 2014
Days to Decision 296 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
181d slower than avg
Panel avg: 115d · This submission: 296d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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