FDA applicant
Togo Medikit Co., Ltd.
FDA records 17 decisions for Togo Medikit Co., Ltd. (Hyuga City, JP) from 1986 to 2024: 17 510(k) clearances. Most are in product codes FOZ (Catheter, Intravascular, Therapeutic…) and DYB (Introducer, Catheter). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 25 predicates, 20 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Togo Medikit Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2011
Class I Class II/III not classified
Planning a device like Togo Medikit 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