Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LQM · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
272 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923313 | ROCHE OXI/FERM II | Roche Diagnostic Systems, Inc. | 1993-04-05 | 272 | 0 |
| K925915 | VITEK RAPID CALL-GRAM NEGATIV IDENT CARD | Biomerieux Vitek, Inc. | 1993-03-23 | 120 | 0 |
| K912897 | SCEPTOR IDENTIFICATION SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-10-28 | 119 | 0 |
| K911429 | VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED | Vitek Systems, Inc. | 1991-06-24 | 90 | 0 |
| K890057 | SENSITITRE AUTO ID PLATE AP80 | Radiometer America, Inc. | 1989-06-09 | 154 | 0 |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | American Micro Scan | 1986-09-11 | 62 | 0 |
| K851528 | PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM | Pasco Laboratories, Inc. | 1985-07-15 | 88 | 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