Cleared Traditional

K150208 - Dakin's Skin and Wound Cleanser

K150208 · Century Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
538d
Days
-
Risk

K150208 is an FDA 510(k) clearance for the Dakin's Skin and Wound Cleanser. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Century Pharmaceuticals, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 21, 2016 after a review of 538 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Century Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K150208

510(k) Number K150208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2015
Decision Date July 21, 2016
Days to Decision 538 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
423d slower than avg
Panel avg: 115d · This submission: 538d
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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