Asahi Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Asahi Medical Co., Ltd.” (first 1983, latest 2004), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 76 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 5 | 5 |
| FJI | Dialyzer, Capillary, Hollow Fiber | 4 | 4 |
| CAK | Microfilter, Blood Transfusion | 3 | 3 |
| MSE | Hemodialyzer, Re-Use, Low Flux | 2 | 2 |
| FLD | Apparatus, Hemoperfusion, Sorbent | 1 | 1 |
| KOC | Accessories, Blood Circuit, Hemodialysis | 1 | 1 |
Review panels
Most recent Asahi Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW FIBER DIALYZER, MODELS APS-R, -M, -S, -E, AND -EX | KDI | 2004-07-23 | 28 |
| K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY | KDI | 2002-07-09 | 267 |
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY MODELS) | KDI | 2000-08-16 | 119 |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | FJI | 1999-07-29 | 90 |
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MODELS AM-BIO-50,AM-BIO-65, AM-BIO-75, AND AM-BIO-100, AM-BIO- | MSE | 1999-05-17 | 208 |
| K970650 | ASAHI AM-R SERIES DIALYZERS | MSE | 1997-09-30 | 222 |
| K914020 | MODIFIED ASAHI PAN-SERIES HEMOFILTERS | KDI | 1992-03-20 | 193 |
| K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | CAK | 1990-08-08 | 104 |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | CAK | 1990-01-24 | 42 |
| K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | CAK | 1990-01-24 | 61 |
6 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2006-10-12.
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 Intecc Co., Ltd. (84 510(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 Medical Co., Ltd.?
FDA lists 16 510(k) clearances under the applicant name “Asahi Medical Co., Ltd.” (first 1983, latest 2004), across 6 product codes in 2 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 Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Asahi Medical Co., Ltd. is 76 days.
Which FDA product codes appear under Asahi Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System, 5); FJI (Dialyzer, Capillary, Hollow Fiber, 4); CAK (Microfilter, Blood Transfusion, 3).
Next steps
- See all 16 Asahi Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KDI, Asahi Medical 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.