Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Consolidated Technology — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K033344 | LIGAND PLUS CONTROL LEVEL 1-3 | Consolidated Technology | 2004-01-16 | 88 | 0 |
| K023731 | QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), | Consolidated Technology | 2002-12-24 | 48 | 0 |
| K020237 | IMMUNOASSAY PLUS CONTROL, LEVELS 1, 2, AND 3 | Consolidated Technology | 2002-03-19 | 55 | 0 |
| K003716 | CONFORMANCE CHEMISTRY CONTROL C3 | Consolidated Technology | 2000-12-20 | 19 | 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