FDA applicant
Hubdic Co., Ltd.
FDA records 6 decisions for Hubdic Co., Ltd. (Bonita Springs, FL) from 2003 to 2020: 6 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and CGA (Glucose Oxidase, Glucose). Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hubdic Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Hubdic Co., Ltd.’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