Asahi Kasei Medical Co., Ltd.: FDA clearances and approvals
Asahi Kasei Medical Co., Ltd. has 5 FDA 510(k) clearances (first 2005, latest 2017), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time: 31 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 271 |
| 2014 | 0 | — |
| 2015 | 1 | 28 |
| 2016 | 0 | — |
| 2017 | 1 | 266 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Asahi Kasei Medical Co., Ltd.'s cleared 510(k)s took a median 266 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 206 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 5 | 5 |
| MDP | Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma | 1 | 0 |
Review panels
Most recent Asahi Kasei Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162248 | Asahi ViE-U Series Dialyzer | KDI | 2017-05-03 | 266 |
| K153344 | Asahi REXEED-S Series Dialyzer | KDI | 2015-12-17 | 28 |
| K121409 | ASAHI REXEED-SX/LX SERIES DIALYZER | KDI | 2013-02-06 | 271 |
| K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX | KDI | 2008-10-03 | 31 |
| K051187 | REXEED SERIES DIALYZERS | KDI | 2005-06-08 | 30 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P820033 | PMA | PLASMAFLO OP-05 W(A) ASAHI PLASMA SEPARATOR | 1983-07-05 |
Recalls
openFDA lists no recalls under a recalling firm named Asahi Kasei Medical 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.
Device clinical trials
Asahi Kasei Medical Co., Ltd. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02292212: Clinical Study of Asahi ViE Dialyzer in Canada (Completed, started 2014-11-24)
Frequently asked questions
How many FDA 510(k) clearances does Asahi Kasei Medical Co., Ltd. have?
Asahi Kasei Medical Co., Ltd. has 5 FDA 510(k) clearances (first 2005, latest 2017), plus 1 PMA decision, across 2 product codes in 1 review panel.
How long does FDA take to clear Asahi Kasei Medical Co., Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Asahi Kasei Medical Co., Ltd.'s cleared 510(k)s is 31 days.
What devices does Asahi Kasei Medical Co., Ltd. make?
Its most frequent FDA product codes are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 5); MDP (Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma, 1).
Has Asahi Kasei Medical Co., Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Asahi Kasei Medical Co., Ltd. Related entities may recall under other names.
Next steps
- See all 5 Asahi Kasei Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Asahi Kasei Medical 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.