Dakin's Skin and Wound Cleanser— 510(k) K150208

Name: FDA 510(k) clearance K150208
Creator: U.S. Food and Drug Administration
Published: 2016-07-21

Substantially Equivalent

Century Pharmaceuticals, Inc.

FDA 510(k) clearance K150208 for Dakin's Skin and Wound Cleanser, Substantially Equivalent on 2016-07-21. Applicant: Century Pharmaceuticals, Inc.. Device class: Unclassified.

Clearance details

Applicant: Century Pharmaceuticals, Inc.
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 2015-01-30
Decision date: 2016-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FRO

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K254041 — SkinSmart Antimicrobial HydroGel2026-09-11
K261646 — Redermax® Antibacterial Wound Matrix2026-08-14
K253665 — Vashe Plus Antimicrobial Solution2026-08-11
K251929 — SilverCeuticals® Antimicrobial Wound Gel2026-06-24
K261023 — Microdacyn Wound Irrigation Solution2026-06-24

More clearances from Century Pharmaceuticals, Inc.

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K090791 — DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5%2009-08-07

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.