Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiodata Corp. — 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) |
|---|---|---|---|---|---|
| K900607 | MK5 DETECTOR & ALARM, ARRHYTHMIA W/SOFTWARE 2.11 | Cardiodata Corp. | 1990-10-16 | 250 | 0 |
| K881488 | HOLTER SCANNER | Cardiodata Corp. | 1988-09-20 | 165 | 0 |
| K873337 | MODEL SSR1 HOLTER MONITOR | Cardiodata Corp. | 1987-10-09 | 51 | 0 |
| K860167 | PRODIGY AND PRODIGY PLUS | Cardiodata Corp. | 1986-03-31 | 73 | 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