Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MSE · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
264 daysmedian FDA review time
567 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K001685 | PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 | Baxter Healthcare Corp | 2000-11-15 | 167 | 0 |
| K983720 | ASAHI AM-BIO SERIES DIALYZERS (WET MODELS)& (DRY MODELS), MO | Asahi Medical Co., Ltd. | 1999-05-17 | 208 | 3 |
| K970700 | FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX | Fresenius USA, Inc. | 1998-09-15 | 567 | 0 |
| K974090 | 95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZER | Fresenius Medical Care North America | 1998-08-27 | 302 | 0 |
| K970661 | CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) | Baxter Healthcare Corp | 1997-11-12 | 264 | 0 |
| K970654 | CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW | Baxter Healthcare Corp | 1997-11-12 | 264 | 0 |
| K970650 | ASAHI AM-R SERIES DIALYZERS | Asahi Medical Co., Ltd. | 1997-09-30 | 222 | 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