Sonoma Pharmaceuticals, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Sonoma Pharmaceuticals, Inc.” (first 2017, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 232 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 4 | 68 |
| 2018 | 1 | 101 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 302 |
| 2025 | 0 | — |
| 2026 | 1 | 86 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sonoma Pharmaceuticals, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 232 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 8 | 8 |
Review panels
Most recent Sonoma Pharmaceuticals, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | FRO | 2026-06-24 | 86 |
| K240510 | Microdacyn Hydrogel | FRO | 2024-11-08 | 260 |
| K233399 | Microdacyn Wound Care Solution | FRO | 2024-09-13 | 345 |
| K173896 | Microcyn Antimicrobial Hydrogel | FRO | 2018-04-02 | 101 |
| K171935 | Alevicyn SG Antimicrobial Gel | FRO | 2017-12-01 | 156 |
| K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | FRO | 2017-11-21 | 81 |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | FRO | 2017-11-15 | 56 |
| K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution | FRO | 2017-07-26 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Sonoma Pharmaceuticals, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Sonoma Pharmaceuticals, Inc. (SNOA): EDGAR filings, CIK 1367083. An SEC registrant with the same name, matched by name only.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Sonoma Orthopedic Products, Inc. (9 510(k)s)
- Sonoma Orthopedics Products, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sonoma Pharmaceuticals, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Sonoma Pharmaceuticals, Inc.” (first 2017, latest 2026), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Sonoma Pharmaceuticals, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sonoma Pharmaceuticals, Inc. is 94 days. Since 2017: 94 days, versus 232 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sonoma Pharmaceuticals, Inc.?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 8).
Next steps
- See all 8 Sonoma Pharmaceuticals, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRO, Sonoma Pharmaceuticals, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.