Cleared Traditional

K261023 - Microdacyn Wound Irrigation Solution

K261023 · Sonoma Pharmaceuticals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
86d
Days
-
Risk

K261023 is an FDA 510(k) clearance for the Microdacyn Wound Irrigation Solution. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Sonoma Pharmaceuticals, Inc. (Boulder, US). The FDA issued a Cleared decision on June 24, 2026 after a review of 86 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, Inc. devices

FDA 510(k) Submission Details - K261023

510(k) Number K261023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2026
Decision Date June 24, 2026
Days to Decision 86 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
29d faster than avg
Panel avg: 115d · This submission: 86d
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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