Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiosonix, Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041180 | QUANTIX OR VESSEL STABILIZER DEVICE | Cardiosonix, Ltd. | 2004-06-07 | 32 | 0 |
| K030357 | QUANTIX/OR DEVICE | Cardiosonix, Ltd. | 2003-08-20 | 198 | 2 |
| K023431 | QUANTIX/ND DEVICE | Cardiosonix, Ltd. | 2002-11-13 | 29 | 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