Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Applied Cardiac Systems — 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) |
|---|---|---|---|---|---|
| K042413 | ACS MODEL NCP-2 | Applied Cardiac Systems | 2004-12-09 | 93 | 0 |
| K860249 | THE HOLTER REPORTER (TM) | Applied Cardiac Systems | 1986-03-11 | 46 | 0 |
| K833823 | HOLTER PERFORMER FEATHER WEIGHT/CASS | Applied Cardiac Systems | 1983-12-01 | 29 | 0 |
| K813602 | HOLTER PERFORMER | Applied Cardiac Systems | 1982-01-29 | 32 | 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