Asahi Intecc Co., Ltd.: FDA clearances and approvals
Asahi Intecc Co., Ltd. has 84 FDA 510(k) clearances (first 2003, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time: 116 days. Since 2017 its median was 136 days, against 124 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 49 |
| 2013 | 3 | 207 |
| 2014 | 2 | 122 |
| 2015 | 4 | 172 |
| 2016 | 9 | 120 |
| 2017 | 3 | 108 |
| 2018 | 4 | 172 |
| 2019 | 7 | 171 |
| 2020 | 2 | 66 |
| 2021 | 2 | 262 |
| 2022 | 4 | 201 |
| 2023 | 1 | 157 |
| 2024 | 4 | 106 |
| 2025 | 7 | 172 |
| 2026 | 2 | 180 |
Review time against the same product codes
Since 2017, Asahi Intecc Co., Ltd.'s cleared 510(k)s took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 124 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | 47 | 47 |
| DQY | Catheter, Percutaneous | 19 | 19 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 10 | 10 |
| QJP | Catheter, Percutaneous, Neurovasculature | 6 | 6 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 | 1 |
Review panels
- Cardiovascular (67)
- Neurology (16)
- Gastroenterology and Urology (1)
Most recent Asahi Intecc Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254178 | SAYA 86 Radial Access Guide Catheter | QJP | 2026-05-11 | 139 |
| K252011 | CHIKAI Nexus petit | MOF | 2026-02-02 | 220 |
| K251560 | FUBUKI XF-R Neurovascular Long Sheath | QJP | 2025-06-20 | 30 |
| K251240 | Branchor X Balloon Guide Catheter | QJP | 2025-06-20 | 59 |
| K243383 | CHIKAI Nexus 014 | MOF | 2025-04-21 | 172 |
| K243733 | SION blue PLUS | DQX | 2025-04-02 | 119 |
| K241962 | Crossloop | DQX | 2025-03-27 | 267 |
| K242597 | CROSSLEAD 0.018inch | DQX | 2025-03-05 | 187 |
| K241702 | CROSSLEAD 0.014inch | DQX | 2025-02-06 | 238 |
| K241801 | Tornus ES | FGE | 2024-12-17 | 179 |
74 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Asahi Intecc Co., Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Asahi Intecc Co., Ltd. have?
Asahi Intecc Co., Ltd. has 84 FDA 510(k) clearances (first 2003, latest 2026), across 6 product codes in 3 review panels.
How long does FDA take to clear Asahi Intecc Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Asahi Intecc Co., Ltd.'s cleared 510(k)s is 116 days. Since 2017: 136 days, versus 124 days for all cleared 510(k)s in the same product codes.
What devices does Asahi Intecc Co., Ltd. make?
Its most frequent FDA product codes are DQX (Wire, Guide, Catheter, 47); DQY (Catheter, Percutaneous, 19); MOF (Guide, Wire, Catheter, Neurovasculature, 10).
Has Asahi Intecc Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Asahi Intecc Co., Ltd. Related entities may recall under other names.
Next steps
- See all 84 Asahi Intecc Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DQX, Asahi Intecc Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.