Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MMW — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
120 daysmedian FDA review time
912 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203245 | Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder E | Nucleix , Ltd. | 2023-05-04 | 912 | 0 |
| K033982 | MODIFICATION TO VYSIS UROVYSION BLADDER CANCER RECURRENCE TE | Vysis | 2004-01-22 | 30 | 0 |
| K021231 | NMP22 BLADDERCHEK KIT, NMP22 CONTROL KIT | Matritech, Inc. | 2002-07-30 | 103 | 0 |
| K013785 | UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2002-02-08 | 86 | 1 |
| K011031 | VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT | Vysis | 2001-08-03 | 120 | 1 |
| K974845 | BTA STAT TEST PRESCRIPTION HOME USE | Bard Diagnostic Sciences,Inc. | 1998-12-08 | 355 | 0 |
| K971402 | BARD BTA TRAK TEST | Bard Diagnostic Sciences,Inc. | 1998-04-15 | 365 | 0 |
| K970353 | AURA TEK FDP | Perimmune, Inc. | 1997-04-30 | 90 | 0 |
| K964151 | BARD AND BTA TEST | Bard Diagnostic Sciences,Inc. | 1997-04-16 | 197 | 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