Asahi Intecc Co., Ltd.: FDA filings under this applicant name
FDA lists 84 510(k) clearances under the applicant name “Asahi Intecc Co., Ltd.” (first 2003, latest 2026), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 116 days. Since 2017 the median was 136 days, against 124 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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, 510(k)s cleared under the name Asahi Intecc Co., Ltd. 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 applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Asahi Medical Co., Ltd. (16 510(k)s)
- Asahi Kasei Medical Co., Ltd. (5 510(k)s)
- Asahi Optical Co. C/O Rosati Associates, P.C. (4 510(k)s)
- Asahi Polyslider Co., Ltd. (2 510(k)s)
- Asahi Intecc USA, Inc. (1 510(k)s)
- Asahi Iryoki Co., Ltd. (1 510(k)s)
- Asahi Kasei Pharma Corporation (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Asahi Intecc Co., Ltd.?
FDA lists 84 510(k) clearances under the applicant name “Asahi Intecc Co., Ltd.” (first 2003, latest 2026), across 6 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Asahi Intecc Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Asahi Intecc Co., Ltd. is 116 days. Since 2017: 136 days, versus 124 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Asahi Intecc Co., Ltd.?
The most frequent FDA product codes under this applicant name are DQX (Wire, Guide, Catheter, 47); DQY (Catheter, Percutaneous, 19); MOF (Guide, Wire, Catheter, Neurovasculature, 10).
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. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.