Cleared Traditional

K171727 - Hydrocleanse Antimicrobial Skin and Wou...

K171727 · Sonoma Pharmaceuticals · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jul 2017
Decision
44d
Days
-
Risk

K171727 is an FDA 510(k) clearance for the Hydrocleanse Antimicrobial Skin and Wound Care Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals (Petaluma, US). The FDA issued a Cleared decision on July 26, 2017 after a review of 44 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sonoma Pharmaceuticals devices

FDA 510(k) Submission Details - K171727

510(k) Number K171727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2017
Decision Date July 26, 2017
Days to Decision 44 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 237
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K171727.
Algidex Ag Silver Alginate Wound Dressing
K173072 · Deroyal Industries, Inc. · Apr 2018
Microcyn Antimicrobial Hydrogel
K173896 · Sonoma Pharmaceuticals, Inc. · Apr 2018
Catasyn Advanced Technology Wound Hydrogel
K172338 · Synedgen, Inc. · Feb 2018
Prontosan Wound Gel
K163430 · B.Braun Medical, Inc. · May 2017
LUOFUCON Silicone Ag Foam Dressing with Border
K170077 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2017
Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL
K161623 · B.Braun Medical, Inc. · Nov 2016