510(k) Report

FDA applicant

Cardiacassist, Inc.

Pittsburgh, PA21 decisions2000–202415 recalls

FDA records 21 decisions for Cardiacassist, Inc. (Pittsburgh, PA) from 2000 to 2024: 21 510(k) clearances. Most are in product codes DWF (Catheter, Cannula And Tubing, Vascular…) and KFM (Pump, Blood, Cardiopulmonary Bypass…). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 32 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 17 of them its own earlier devices. 15 recalls are linked to its devices, 2 Class I.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardiacassist, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 12011: 12012: 12014: 32016: 32017: 12018: 12019: 12021: 12022: 12023: 22024: 1
2007high 3 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2023

2010: 12019: 12020: 82021: 22022: 2, 2 Class I2023: 1
2007high 8 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardiacassist, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiacassist, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass9decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type4decisions
  • QNRBlood Pump For Ecmo, Long-Term (> 6 Hours) Use3decisions
  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • DQRCannula, Catheter1decision
  • DWAControl, Pump Speed, Cardiopulmonary Bypass1decision

Also: PZS (1), DTZ (1).

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 105 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 32 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 33 predicates; 17 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 25 times; 17 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991783AB-180 XC System, Model AB-180XCCardiacassist, Inc. · 20003cite it
  • K140999Tandemheart Veno-Venous CannulaCardiacassist, Inc. · 20143cite it
  • K160257PROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. · 20163cite it
  • K133236Tandemheart Femoral Venous Cannula SetCardiacassist, Inc. · 20142cite it
  • K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 20062cite it
  • K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 20032cite it

What has FDA decided for it lately?

  • K233736LifeSPARC SystemCardiacassist, Inc. · 2024
  • K232480ProtekDuo Veno-Venous Cannula SetsCardiacassist, Inc. · 2023
  • K232132LifeSPARC SystemCardiacassist, Inc. · 2023
  • K211830LifeSPARC SystemCardiacassist, Inc. · 2022
  • K202751TandemHeart Pump and Escort ControllerCardiacassist, Inc. · 2021
  • K183623LifeSPARC Pump, LifeSPARC ControllerCardiacassist, Inc. · 20192 Class I recalls
  • K181150ProtekDuo Mini Veno-Venous Cannula SetCardiacassist, Inc. · 2018
  • K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator SetCardiacassist, Inc. · 20171 recall

All 21 as Cardiacassist, Inc. →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K183623LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming…Jun 30, 2023Class II
  • K183623SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC…Dec 5, 2022Class I
  • K183623TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000…Jul 21, 2022Class I
  • K160257SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass.…Oct 14, 2021Class III
  • K162181Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization.…Mar 19, 2021Class II
  • K110493TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product…Mar 6, 2020Class II