Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiomedics, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
114 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K050172 | CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 | Cardiomedics, Inc. | 2005-03-31 | 64 | 1 |
| K023427 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | Cardiomedics, Inc. | 2003-01-07 | 88 | 0 |
| K022107 | CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 | Cardiomedics, Inc. | 2002-08-08 | 41 | 0 |
| K010261 | CARDIOMEDICS ECP SYSTEM | Cardiomedics, Inc. | 2001-02-28 | 30 | 0 |
| K872034 | CARDIOMEDICS EXTERNAL COUNTERPULSATION SYSTEM | Cardiomedics, Inc. | 1987-09-18 | 114 | 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