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

Gish Biomedical, Inc. · Predicate Candidate Screening

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

86 daysmedian FDA review time
272 days90th percentile
75clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTGish Biomedical, Inc.2009-09-182100
K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTGish Biomedical, Inc.2009-09-182100
K091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730Gish Biomedical, Inc.2009-08-041120
K083131MEDOS HILITE RESERVOIR, MODEL: 4030Gish Biomedical, Inc.2009-07-302800
K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTGish Biomedical, Inc.2009-05-152670
K082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATINGGish Biomedical, Inc.2009-02-041960
K081947GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATINGGish Biomedical, Inc.2009-02-042110
K080708VISION HOLLOW FIBER OXYGENATOR WITH HA COATINGGish Biomedical, Inc.2009-02-023270
K081838GISH VISION BLOOD CARDIOPLEGIA WITH HA COATINGGish Biomedical, Inc.2009-01-262100
K081881GISH TUBING AND CONNECTORS WITH HA COATINGGish Biomedical, Inc.2009-01-232050
K081054GISH ARTERIAL FILTER WITH HA COATINGGish Biomedical, Inc.2009-01-152760
K051606GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATINGGish Biomedical, Inc.2005-08-12570
K050195V-BAG WITH GBS COATINGGish Biomedical, Inc.2005-03-17490
K040355VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPORAL HEAT EXCHGish Biomedical, Inc.2004-03-15321
K030726GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH GBS COATINGGish Biomedical, Inc.2003-05-30840
K031300IBC FLOPUMP WITH GBS COATINGGish Biomedical, Inc.2003-05-14200
K023381VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATINGGish Biomedical, Inc.2003-03-311742
K023833GISH ARTERIAL FILTER WITH GBS COATINGGish Biomedical, Inc.2003-03-311330
K030077GISH TUBING AND CONNECTORS WITH GBS COATINGGish Biomedical, Inc.2003-03-14650
K024065SOFT VENOUS RESERVOIR (SVRXX) WITH GBS COATINGGish Biomedical, Inc.2003-03-05860
K020106VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCGish Biomedical, Inc.2002-04-10890
K964973GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIRGish Biomedical, Inc.1997-03-10880
K961530GISH RELIANCE OXYGENATOR (MODEL HFO)Gish Biomedical, Inc.1996-12-052271
K955046SOFT VENOUS RESERVOIRGish Biomedical, Inc.1996-01-11690
K954433VASPORT DUAL LUMEN VASCULAR ACCESS SYSTEMGish Biomedical, Inc.1995-11-15510
K953571VASPORT VASCULAR ACCESS PORTGish Biomedical, Inc.1995-10-02630
K944219SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTSGish Biomedical, Inc.1995-06-303050
K936286ATR-2900DF (WITH DEPTH FILTER)/CAP-35DF (WITH DEPTH FILTER)Gish Biomedical, Inc.1994-02-14760
K922840ANTEGRADE/RETROGRADE CARDIOPLEGIA VALVE SYSTEMSGish Biomedical, Inc.1993-05-173390
K914791GISH ARTERIAL FILTERGish Biomedical, Inc.1993-04-065310
K913691CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIESGish Biomedical, Inc.1991-12-181210
K912019ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEMGish Biomedical, Inc.1991-10-081540
K911519CATHCAP, CAT. NO. CC100 SERIESGish Biomedical, Inc.1991-05-22480
K910868TEMPERATURE WELL PROBE, TWP SERIESGish Biomedical, Inc.1991-04-22520
K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, Inc.1991-01-23780
K896807SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEMGish Biomedical, Inc.1990-07-312390
K896020EXTRACORPOREAL HEAT EXCHANGER HE SERIESGish Biomedical, Inc.1990-05-172130
K892443BLOOD RECOVERY/AUTOTRANSFUSION RESERVOIR ATR-2900Gish Biomedical, Inc.1989-11-082120
K893649MECONIUM ASPIRATORGish Biomedical, Inc.1989-08-21980
K891906ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.1989-06-13780
K890504CARDIOTOMY/AUTOTRANSFUSION/PLEURAL DRAINAGE VENOUSGish Biomedical, Inc.1989-03-10370
K882414BLOOD RESERVOIR, CARDIOPULMONARY BYPASSGish Biomedical, Inc.1988-12-051750
K883923CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIESGish Biomedical, Inc.1988-11-04490
K882969VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORTGish Biomedical, Inc.1988-09-26730
K874839STAT-SATGish Biomedical, Inc.1988-05-131710
K874924CAP-35 AND CAP35 FGish Biomedical, Inc.1988-01-19480
K873377CLOSED CHEST DRAINAGE SET W/SUTURESGish Biomedical, Inc.1987-10-28650
K873035VASCULAR ACCESS PORT/CATH CAT. #VP-XXX VASPORT SERGish Biomedical, Inc.1987-09-25520
K871774CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETSGish Biomedical, Inc.1987-08-03890
K871873CLOSED CHEST DRAINAGE SETGish Biomedical, Inc.1987-07-09570

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