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

Sorin Biomedical, Inc. — Predicate Candidate Screening

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

240 daysmedian FDA review time
520 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K990103MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTESorin Biomedical, Inc.1999-11-052970
K963758CODE 150 BLOOD COMPONENT COLLECTION SET AND WITH DIRECT DRAWSorin Biomedical, Inc.1998-02-205200
K963759DIDECO COMPACT-A AND COMPACT-M AUTOTRANSFUSION SYSTEMSSorin Biomedical, Inc.1998-02-205200
K964908VRF40 VENOUS RESERVOIR WITH INTEGRAL CARDIOTOMY FILTERSorin Biomedical, Inc.1997-09-032680
K964907VENOMIDICARD PEDIATRIC VENOUS RESERVOIR WITH INTEGRALCARDIOTSorin Biomedical, Inc.1997-08-212550
K961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D7Sorin Biomedical, Inc.1996-08-12890
K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICROSorin Biomedical, Inc.1995-08-21980
K945198DIDECO PEDIATRIC ARTERIAL FILTERSSorin Biomedical, Inc.1995-06-272460
K945065DIDECO FLEXIBLE RESERVOIR -- PRODUCT DESIGNATION 5063Sorin Biomedical, Inc.1995-05-192170
K941215VENOMIDICARD INFANT/ PEDIATRIC VENOUS CARDIOTOMY RESERVOIRSorin Biomedical, Inc.1995-05-104260
K942582SORIN BLOOD CARDIOPLEGIA CONSOLESorin Biomedical, Inc.1995-01-272400
K934847NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMSSorin Biomedical, Inc.1994-04-151892
K934763SORIN BLOOD CARDIOPLEGIA SYSTEMSorin Biomedical, Inc.1994-04-151920
K936183SORIN BCD ADVANCED PEDIATRIC BLOOD CARDIOPLEGIA SYSTEMSSorin Biomedical, Inc.1994-03-23860
K933481SORIN MONOLYTH VENOUS RESERVOIRSorin Biomedical, Inc.1993-11-021250

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