FDA applicant
Sonoma Pharmaceuticals, Inc.
FDA records 8 decisions for Sonoma Pharmaceuticals, Inc. (Petaluma, CA) from 2017 to 2026: 8 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 94 days from receipt to decision, against 177 for FDA’s reviews in the same codes and years. Its devices cite 13 predicates, 5 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Sonoma Pharmaceuticals”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sonoma Pharmaceuticals, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Sonoma Pharmaceuticals, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sonoma”
FDA records each applicant name separately; these may or may not be the same firm.