Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Asahi Medical Co., Ltd. — Predicate Candidate Screening
16 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
222 days90th percentile
16clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041726 | HIGH FLUX HEMODIALYSIS MEMBRANE DIALYZER OR HIGH FLUX HOLLOW | Asahi Medical Co., Ltd. | 2004-07-23 | 28 | 1 |
| K013418 | AM-BIO EXTENDED RANGE SERIES DIALYZER, MODELS WET AND DRY | Asahi Medical Co., Ltd. | 2002-07-09 | 267 | 1 |
| K001250 | APS SERIES DIALYZERS (WET MODELS), APS SERIES DIALYSIS (DRY | Asahi Medical Co., Ltd. | 2000-08-16 | 119 | 2 |
| K991512 | ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X | Asahi Medical Co., Ltd. | 1999-07-29 | 90 | 1 |
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MO | Asahi Medical Co., Ltd. | 1999-05-17 | 208 | 3 |
| K970650 | ASAHI AM-R SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1997-09-30 | 222 | 0 |
| K914020 | MODIFIED ASAHI PAN-SERIES HEMOFILTERS | Asahi Medical Co., Ltd. | 1992-03-20 | 193 | 0 |
| K901887 | MODIFIED SEPACELL R-SERIES BLOOD FILTERS | Asahi Medical Co., Ltd. | 1990-08-08 | 104 | 0 |
| K896976 | MODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERS | Asahi Medical Co., Ltd. | 1990-01-24 | 42 | 0 |
| K896664 | MODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILT | Asahi Medical Co., Ltd. | 1990-01-24 | 61 | 0 |
| K892375 | MODIFIED AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1989-05-18 | 48 | 0 |
| K892374 | NEW AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1989-05-18 | 48 | 0 |
| K885017 | HEMOSORBA CH-500, CH-350 AND CH-180 | Asahi Medical Co., Ltd. | 1989-03-17 | 102 | 0 |
| K854575 | MODIFIED AM-SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1985-12-02 | 26 | 0 |
| K844663 | ASAHI NEW PAN-SERIES HEMOFILTERS | Asahi Medical Co., Ltd. | 1985-01-18 | 49 | 0 |
| K833150 | ASAHI HOLLOW FIBER KIDNEYS, EXCEL | Asahi Medical Co., Ltd. | 1983-11-15 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda