Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Asahi Kasei Medical Co., Ltd. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
271 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162248 | Asahi ViE-U Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2017-05-03 | 266 | 0 |
| K153344 | Asahi REXEED-S Series Dialyzer | Asahi Kasei Medical Co., Ltd. | 2015-12-17 | 28 | 0 |
| K121409 | ASAHI REXEED-SX/LX SERIES DIALYZER | Asahi Kasei Medical Co., Ltd. | 2013-02-06 | 271 | 0 |
| K082515 | ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX | Asahi Kasei Medical Co., Ltd. | 2008-10-03 | 31 | 7 |
| K051187 | REXEED SERIES DIALYZERS | Asahi Kasei Medical Co., Ltd. | 2005-06-08 | 30 | 1 |
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