FDA applicant
Asahi Intecc Co., Ltd.
FDA records 84 decisions for Asahi Intecc Co., Ltd. (Seto, JP) from 2003 to 2026: 84 510(k) clearances. Most are in product codes DQX (Wire, Guide, Catheter) and DQY (Catheter, Percutaneous). Since 2016 its 510(k)s took a median of 133 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 222 predicates, 139 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 Asahi Intecc Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
7in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Asahi Intecc 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) ReportOther applicant names beginning “Asahi”
FDA records each applicant name separately; these may or may not be the same firm.