Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MVJ — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
218 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K071219 | ATHENA MULTI-LYTE GBM TEST SYSTEM | Zeus Scientific, Inc. | 2007-12-06 | 218 | 0 |
| K072358 | BIOPLEX VASCULITIS KIT | Bio-Rad Laboratories | 2007-10-31 | 70 | 0 |
| K011348 | PHASE II GBM IGG ANTIBODY EIA TEST | Scimedx Corp. | 2001-06-25 | 54 | 0 |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Cogent Diagnotics , Ltd. | 1999-08-09 | 67 | 0 |
| K984619 | BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT | The Binding Site, Ltd. | 1999-02-23 | 56 | 0 |
| K984336 | QUANTA LITE GBM ELISA | Inova Diagnostics, Inc. | 1999-02-08 | 67 | 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