Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sonoma Pharmaceuticals, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
156 daysmedian FDA review time
345 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | Sonoma Pharmaceuticals, Inc. | 2026-06-24 | 86 | 0 |
| K240510 | Microdacyn Hydrogel | Sonoma Pharmaceuticals, Inc. | 2024-11-08 | 260 | 0 |
| K233399 | Microdacyn Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2024-09-13 | 345 | 0 |
| K173896 | Microcyn Antimicrobial Hydrogel | Sonoma Pharmaceuticals, Inc. | 2018-04-02 | 101 | 0 |
| K171935 | Alevicyn SG Antimicrobial Gel | Sonoma Pharmaceuticals, Inc. | 2017-12-01 | 156 | 0 |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | Sonoma Pharmaceuticals, Inc. | 2017-11-15 | 56 | 1 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda