Atlas FDA

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

Sorin Group Deutschland GmbH · Predicate Candidate Screening

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

84 daysmedian FDA review time
258 days90th percentile
20clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K170460Sorin ConnectSorin Group Deutschland GmbH2017-06-081130
K131553XTRASorin Group Deutschland GmbH2014-03-212950
K140012SORIN FLEXTHERMSorin Group Deutschland GmbH2014-01-31290
K131816SORIN CONNECT DATA MANAGEMENT SYSTEMSorin Group Deutschland GmbH2013-07-23330
K112225SORIN CENTRIFUGAL PUMP 5 (CP5)Sorin Group Deutschland GmbH2011-09-20482
K103762SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150Sorin Group Deutschland GmbH2011-01-20280
K103468STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/CSorin Group Deutschland GmbH2011-01-20570
K103469STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbH2011-01-18550
K103168B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MESorin Group Deutschland GmbH2011-01-06710
K101046STOCKERT S5 SYSTEM AND GAS BLENDER AND SORIN C5 SYSTEMSorin Group Deutschland GmbH2010-12-092390
K093882SORIN C5 SYSTEM MODEL 58-00-00Sorin Group Deutschland GmbH2010-01-15287
K092463SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEMSorin Group Deutschland GmbH2009-11-05861
K091008STOCKERT CENTRIFUGAL PUMP PLUS SYSTEM (SCP PLUS), MODELS 60-Sorin Group Deutschland GmbH2009-07-15970
K091007AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05Sorin Group Deutschland GmbH2009-07-02840
K082344STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVOSorin Group Deutschland GmbH2008-12-171241
K080832STOCKERT S5 SYSTEM, STOCKERT GAS BLENDERSorin Group Deutschland GmbH2008-07-301270
K071318MODIFICATION TO: STOCKERT S5 SYSTEMSorin Group Deutschland GmbH2007-07-065712
K062396MODIFICATION TO STOCKERT S5 SYSTEMSorin Group Deutschland GmbH2006-09-28431
K052601STOCKERT HEATER-COOLER SYSTEM 3TSorin Group Deutschland GmbH2006-06-0625815
K060053STOCKERT S5 SYSTEMSorin Group Deutschland GmbH2006-06-0214720

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