Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio Data — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
67 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K853262 | CARDIO DATA PACERECORDER PR3 | Cardio Data | 1985-10-11 | 67 | 0 |
| K850136 | CARDIO DATA MK4 HOLTER ANALYSIS SYSTEM | Cardio Data | 1985-02-01 | 18 | 0 |
| K834257 | CARDIODATA PACE RECORDER | Cardio Data | 1984-01-30 | 54 | 0 |
| K831184 | CARDIO DATA PACEMAKER RECORDER | Cardio Data | 1983-05-09 | 28 | 0 |
| K812149 | CARDIO-DATA SYSTEM, #MARK III | Cardio Data | 1981-08-31 | 34 | 0 |
| K770264 | PACEGUARD | Cardio Data | 1977-02-16 | 5 | 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