Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Eucardio Laboratory, Inc. — 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) |
|---|---|---|---|---|---|
| K942464 | UC QIK 1-STEP HCG TEST | Eucardio Laboratory, Inc. | 1994-09-20 | 119 | 0 |
| K926500 | UC QIK PREGNANCY TEST | Eucardio Laboratory, Inc. | 1993-06-07 | 160 | 0 |
| K904137 | UC IMU B | Eucardio Laboratory, Inc. | 1990-11-21 | 76 | 0 |
| K904125 | UC IMU A | Eucardio Laboratory, Inc. | 1990-09-24 | 18 | 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