K150208 - Dakin's Skin and Wound Cleanser (FDA 510(k) Clearance)

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