Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio Systems, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
133 daysmedian FDA review time
234 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131092 | STEALTH 360 ORBITAL PAD SYSTEM | Cardio Systems, Inc. | 2013-06-24 | 67 | 0 |
| K081944 | MODIFICATION TO DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY S | Cardio Systems, Inc. | 2008-08-14 | 37 | 0 |
| K972022 | ZAK-2000 | Cardio Systems, Inc. | 1998-01-22 | 234 | 0 |
| K934689 | LOW AIR LOSS MATTRESS, MODIFICATION | Cardio Systems, Inc. | 1994-02-02 | 163 | 0 |
| K921500 | CENTRI-SAFE(TM) VALVE | Cardio Systems, Inc. | 1992-09-15 | 168 | 0 |
| K882177 | ADD-ON TO CRITICAL PATIENT CARE BED | Cardio Systems, Inc. | 1988-12-01 | 191 | 0 |
| K852736 | BAYLOR RAPID AUTOTRANSFUSION SYSTEM | Cardio Systems, Inc. | 1985-09-18 | 133 | 0 |
| K792152 | CARDIOPLEGIA SOLUTION ADMIN. SET | Cardio Systems, Inc. | 1979-11-13 | 22 | 0 |
| K792151 | OXYGENATOR GAS LINE FILTER | Cardio Systems, Inc. | 1979-11-13 | 22 | 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