Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MKW — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
475 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K080751 | ARCHITECT CYCLOSPORINE | Fujirebio Diagnostics,Inc. | 2008-09-11 | 177 | 1 |
| K071455 | ADVIA CENTAUR CYCLOSPORINE ASSAY AND CALIBRATOR | Siemens Medical Solutions Diagnostics | 2008-09-11 | 475 | 1 |
| K081992 | DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 | Siemens Healthcare Diagnostics, Inc. | 2008-08-05 | 22 | 0 |
| K062236 | DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2006-08-21 | 19 | 2 |
| K053061 | EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY | Dade Behring, Inc. | 2006-02-06 | 98 | 0 |
| K052017 | CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRI | Dade Behring, Inc. | 2005-09-01 | 37 | 0 |
| K040761 | AXSYM CYCLOSPORINE | Abbott Laboratories, Inc. | 2004-04-30 | 36 | 0 |
| K023208 | CEDIA CYCLOSPORINE PLUS ASSAY | Microgenics Corp. | 2002-10-24 | 29 | 0 |
| K023065 | CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2002-10-16 | 30 | 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