Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardionostics, 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) |
|---|---|---|---|---|---|
| K902486 | CARDIOVISTA | Cardionostics, Inc. | 1990-08-23 | 80 | 0 |
| K863863 | CARDIONOSTICS HOLTER DURA-LITE RECORDER (CASSETTE) | Cardionostics, Inc. | 1986-10-15 | 12 | 0 |
| K844977 | HOLTER CURA-LITE RECORDER | Cardionostics, Inc. | 1985-01-14 | 19 | 0 |
| K842954 | CARDIONOSTICS HOLTER DURA-LITE RECORDE | Cardionostics, Inc. | 1984-09-04 | 39 | 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