Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
LQL — Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
183 daysmedian FDA review time
277 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972576 | GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90 | Accumed Intl., Inc. | 1998-01-22 | 196 | 0 |
| K961730 | RAPID GRAM-POSITIVE ID SYSTEM | Becton Dickinson Microbiology Systems | 1997-02-04 | 277 | 0 |
| K961968 | BBLCRYSTAL GRAM-POSITIVE ID SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1997-02-04 | 260 | 0 |
| K952095 | VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI) | Biomerieux Vitek, Inc. | 1996-03-12 | 313 | 0 |
| K925916 | VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD | Biomerieux Vitek, Inc. | 1993-03-23 | 120 | 0 |
| K910304 | RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA | Vitek Systems, Inc. | 1991-07-26 | 183 | 0 |
| K910537 | VISI-STREP | Kev Connecticut Diagnostics, Inc. | 1991-04-12 | 63 | 0 |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | Analytical Products, Inc. | 1990-09-10 | 160 | 0 |
| K891004 | RAPIDEC STAPH | Dms Products, Inc. | 1989-11-09 | 254 | 0 |
| K874606 | CATHRA GRAM POSITIVE SCREEN | Mct Medical, Inc. | 1988-05-06 | 179 | 0 |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | 1986-09-30 | 49 | 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