Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LSC — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
46 daysmedian FDA review time
58 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840506 | HAEMOPHILUS INFLUENZAE TYPE B | Scientific Device Laboratory, Inc. | 1984-04-04 | 58 | 0 |
| K840509 | NEISSERIA MENINGITIDIS GR. B | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840505 | SDL NEISSERIA MENNINGITIDIS GR. X | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840504 | SDL NEISSERIA MENINGITIDES GR. 2 | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840507 | NEISSERIA MENINGITIDIS GR. Y | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840510 | NEISSERIA MENINGITIDIS GR. A | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 0 |
| K840514 | NEISSERIA MENINGITIDIS CONTROL | Scientific Device Laboratory, Inc. | 1984-03-23 | 46 | 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