Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLR — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
55 daysmedian FDA review time
113 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K090282 | QMS LIDOCAINE | Thermo Fisher Scientific, Inc. | 2009-05-29 | 113 | 0 |
| K033809 | DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DI | Dade Behring, Inc. | 2004-02-20 | 74 | 0 |
| K032334 | ROCHE ONLINE TDM LIDOCAINE | Roche Diagnostics Corp. | 2004-01-12 | 167 | 0 |
| K973102 | LIDOCAINE EIA ASSAY | Diagnostic Reagents, Inc. | 1997-09-12 | 24 | 0 |
| K881116 | EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 | Diagnostic Systems | 1988-06-20 | 97 | 0 |
| K853010 | COBAS REAGENT FOR LIDOCAINE & CALIBRATORS | Roche Diagnostic Systems, Inc. | 1985-08-07 | 22 | 0 |
| K843184 | STRATUS LIDOCAINE FLUOROMETRIC ENZYME | American Dade | 1984-09-26 | 44 | 0 |
| K833379 | LIDOCAINE ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 | 89 | 0 |
| K833381 | VALPROIC ACID ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 | 89 | 0 |
| K833623 | MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY | Syva Co. | 1983-12-08 | 55 | 0 |
| K832799 | MODIFICA- OF EMIT CAD LIDOCAINE ASSAY | Syva Co. | 1983-10-14 | 57 | 0 |
| K831354 | EMIT QST LIDOCAINE ASSAY | Syva Co. | 1983-05-27 | 31 | 0 |
| K823887 | ADVANCE EMIT CAD DISOPYRAMIDE ASSAY | Syva Co. | 1983-01-28 | 32 | 0 |
| K823866 | ADVANCE EMIT CAD LIDOCAINE ASSAY | Syva Co. | 1983-01-12 | 20 | 0 |
| K822347 | LIDOCAINE FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-08-25 | 19 | 0 |
| K802131 | CYBREX LIDOCAINE | Abbott Laboratories | 1980-10-31 | 57 | 0 |
| K801204 | EMIT DISOPYRAMIDE ASSAY | Syva Co. | 1980-06-09 | 21 | 1 |
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