510(k) Report

FDA applicant

Levitronix, LLC

Waltham, MA11 decisions2003–20114 recalls

FDA records 11 decisions for Levitronix, LLC (Waltham, MA) from 2003 to 2011: 11 510(k) clearances. Most are in product codes DWA (Control, Pump Speed, Cardiopulmonary Bypass) and KFM (Pump, Blood, Cardiopulmonary Bypass…). Its devices cite 16 predicates, 11 of them its own earlier devices. 4 recalls are linked to its devices, 1 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 Levitronix, LLC’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2008: 22009: 22010: 22011: 2
2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2019

2008: 22018: 12019: 1, 1 Class I
2007high 2 (2008) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Levitronix, LLC’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?

  • DWAControl, Pump Speed, Cardiopulmonary Bypass6decisions
  • KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type3decisions
  • DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass2decisions

Whose devices does it build on?

Its devices cite 16 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 11 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.

  • K020271Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100Levitronix, LLC · 200310cite it
  • K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC · 20083cite it
  • K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC · 20102cite it
  • K110980Centrimag Return Cannula KitLevitronix, LLC · 20111cites it
  • K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC · 20081cites it
  • K110983Centrimag Drainage Cannula KitLevitronix, LLC · 20111cites it

What has FDA decided for it lately?

  • K110980Centrimag Return Cannula KitLevitronix, LLC · 2011
  • K110983Centrimag Drainage Cannula KitLevitronix, LLC · 2011
  • K102129Levitronix 2ND Generation Centrimag Primary Console, Levitronix MonitorLevitronix, LLC · 2010
  • K093832Levitronix Centrimag Primary and Backup ConsolesLevitronix, LLC · 2010
  • K090051Levitronix Pedimag Blood Pump, Model 201-90052Levitronix, LLC · 20091 recall
  • K090004Levitronix, Thoratec Centrimag Back-UP ConsolesLevitronix, LLC · 20091 recall
  • K083340Levitronix Centrimag Primary Console; Thoratec Cantrimag Primary ConsoleLevitronix, LLC · 20081 recall
  • K081221Levitronix Centrimag Primary Console, Thoratec Centrimag Primary ConsoleLevitronix, LLC · 2008

All 11 as Levitronix, LLC →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K020271CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model…Aug 22, 2019Class I
  • K090004Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood…Sep 5, 2018Class II
  • K051209Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood…Mar 17, 2008
  • K020271Levitronix CentriMag Primary System, Article Number: 201-30100; extracorporeal blood…Mar 17, 2008