FDA applicant
Hobbs Medical, Inc.
FDA records 21 decisions for Hobbs Medical, Inc. (Stafford Springs, CT) from 1983 to 2024: 21 510(k) clearances. Most are in product codes OCX (Endoscopic Irrigation/Suction System) and FGE (Stents, Drains And Dilators For The Biliary…). Its devices cite 1 predicate, 1 of them its own earlier devices. 55 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hobbs Medical, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
52in 2022
Class I Class II/III not classified
Planning a device like Hobbs Medical, 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) Report