Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiac Designs, LLC — Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131045 | ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE | Cardiac Designs, LLC | 2013-05-29 | 44 | 0 |
| K122184 | ECG CHECK | Cardiac Designs, LLC | 2013-02-14 | 206 | 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