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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Levitronix, LLC — Predicate Candidate Screening

11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

50 daysmedian FDA review time
274 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K110983CENTRIMAG DRAINAGE CANNULA KITLevitronix, LLC2011-06-20740
K110980CENTRIMAG RETURN CANNULA KITLevitronix, LLC2011-06-20740
K102129LEVITRONIX 2ND GENERATION CENTRIMAG PRIMARY CONSOLE, LEVITROLevitronix, LLC2010-08-27290
K093832LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLESLevitronix, LLC2010-01-13300
K090051LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052Levitronix, LLC2009-10-082741
K090004LEVITRONIX, THORATEC CENTRIMAG BACK-UP CONSOLESLevitronix, LLC2009-01-15131
K083340LEVITRONIX CENTRIMAG PRIMARY CONSOLE; THORATEC CANTRIMAG PRILevitronix, LLC2008-11-26141
K081221LEVITRONIX CENTRIMAG PRIMARY CONSOLE, THORATEC CENTRIMAG PRILevitronix, LLC2008-06-19500
K053630LEVITRONIX CENTRIMAG PRIMARY CONSOLELevitronix, LLC2006-01-26280
K051209LEVITRONIX CENTRIMAG BACK-UP CONSOLELevitronix, LLC2005-09-081201
K020271LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MOLevitronix, LLC2003-03-254213

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