Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiacassist, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
210 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233736 | LifeSPARC System | Cardiacassist, Inc. | 2024-01-19 | 58 | 0 |
| K232480 | ProtekDuo Veno-Venous Cannula Sets | Cardiacassist, Inc. | 2023-10-06 | 51 | 0 |
| K232132 | LifeSPARC System | Cardiacassist, Inc. | 2023-08-03 | 16 | 0 |
| K211830 | LifeSPARC System | Cardiacassist, Inc. | 2022-11-15 | 519 | 0 |
| K202751 | TandemHeart Pump and Escort Controller | Cardiacassist, Inc. | 2021-03-26 | 186 | 0 |
| K183623 | LifeSPARC Pump, LifeSPARC Controller | Cardiacassist, Inc. | 2019-07-09 | 195 | 3 |
| K181150 | ProtekDuo Mini Veno-Venous Cannula Set | Cardiacassist, Inc. | 2018-05-25 | 24 | 0 |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Se | Cardiacassist, Inc. | 2017-01-06 | 155 | 0 |
| K162214 | Protek Solo 24 Fr Venous Cannula Set | Cardiacassist, Inc. | 2016-11-30 | 114 | 0 |
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set | Cardiacassist, Inc. | 2016-03-04 | 32 | 0 |
| K153295 | TandemLung Oxygenator | Cardiacassist, Inc. | 2016-02-26 | 105 | 0 |
| K140999 | TANDEMHEART VENO-VENOUS CANNULA | Cardiacassist, Inc. | 2014-08-06 | 110 | 0 |
| K133293 | 15 FR. TANDEMHEART ARTERIAL CANNULA | Cardiacassist, Inc. | 2014-02-12 | 110 | 0 |
| K133236 | TANDEMHEART FEMORAL VENOUS CANNULA SET | Cardiacassist, Inc. | 2014-01-29 | 100 | 0 |
| K120543 | TANDEMHEART FEMORAL ARTERIAL CANNULA SET | Cardiacassist, Inc. | 2012-05-30 | 97 | 0 |
| K110493 | TANDEMHEART PUMP | Cardiacassist, Inc. | 2011-09-20 | 210 | 0 |
| K082425 | TANDEMHEART TRANSSEPTAL CANNULA- EF 72 | Cardiacassist, Inc. | 2008-09-18 | 27 | 0 |
| K061369 | TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500 | Cardiacassist, Inc. | 2006-08-22 | 97 | 0 |
| K052570 | TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221 | Cardiacassist, Inc. | 2006-01-17 | 120 | 1 |
| K030398 | CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 | Cardiacassist, Inc. | 2003-05-23 | 106 | 0 |
| K991783 | AB-180 XC SYSTEM, MODEL AB-180XC | Cardiacassist, Inc. | 2000-11-01 | 526 | 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