Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiac Recorders, Ltd. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
119 daysmedian FDA review time
136 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864704 | CARDIAN III CR6A | Cardiac Recorders, Ltd. | 1987-03-20 | 108 | 0 |
| K861621 | CARDIAN II CR45A | Cardiac Recorders, Ltd. | 1986-09-12 | 136 | 0 |
| K853673 | CARDIORATER CR 51 | Cardiac Recorders, Ltd. | 1985-12-11 | 98 | 0 |
| K852910 | CARDIORATER CR7 | Cardiac Recorders, Ltd. | 1985-11-19 | 133 | 0 |
| K852887 | CR5 CARDIAC MONITOR | Cardiac Recorders, Ltd. | 1985-11-14 | 128 | 0 |
| K852905 | CR 280/45, CR281/4 DEFIBRILLATOR | Cardiac Recorders, Ltd. | 1985-11-05 | 119 | 0 |
| K852799 | 2006, 2010, 2011, 2012(CARDIAC DC DEFIBRILLATOR) | Cardiac Recorders, Ltd. | 1985-09-16 | 77 | 0 |
| K852808 | CR26, CR26A, CR26B, CR26C(CARDIAC DC DEFIBRILLATO) | Cardiac Recorders, Ltd. | 1985-09-16 | 76 | 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