Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NDW — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
121 daysmedian FDA review time
465 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243462 | Diazyme Colorimetric Lithium Assay | Diazyme Laboratories, Inc. | 2025-08-01 | 266 | 0 |
| K112142 | DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2011-11-04 | 101 | 1 |
| K063684 | COBAS LITHIUM | Roche Diagnostics Corp. | 2008-03-21 | 465 | 0 |
| K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATOR | Thermo Electron OY | 2007-10-09 | 300 | 0 |
| K070987 | SENTINEL LITHIUM ASSAY | SENTINEL CH. SpA | 2007-08-02 | 118 | 0 |
| K050374 | ADVIA IMS LITHIUM ASSAY | Bayer Healthcare, LLC | 2005-06-15 | 121 | 3 |
| K003583 | LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901 | Trace America, Inc. | 2001-01-17 | 58 | 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