FDA 510(k) Applications for Medical Device Product Code "LHI"
(Set, I.V. Fluid Transfer)

FDA 510(k) Number Applicant Device Name Decision Date
K024239 ABBOTT LABORATORIES CHEMO DISPENSING PIN, MODEL 12495 01/13/2003
K960466 ABBOTT LABORATORIES IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) 05/29/1996
K901404 ABBOTT LABORATORIES NUTRIMIX MACRO TPN COMPOUNDER 06/26/1990
K921365 ABBOTT LABORATORIES NUTRIMIX MICROCOMPOUNDER 06/30/1992
K910213 ABBOTT LABORATORIES NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION 04/16/1991
K912771 ACACIA, INC. ACACIAS PHARM/PUMP 02/14/1992
K853212 ACACIA, INC. FLOW EASE(PLASTIC VENTED NEEDLE) 09/19/1985
K901063 ACACIA, INC. LUER LOCK TRANSFER PIN 07/06/1990
K896990 ACACIA, INC. PHARMULATOR 03/23/1990
K850757 ACACIA, INC. TANDEM SETS I.V. 04/04/1985
K820937 ACKRAD LABORATORIES ACKRAD FLUID CONNECTING SET 04/26/1982
K853188 ADVANCE MEDICAL DESIGNS, INC. TRANSFER DEVICE 08/21/1985
K013087 ALARIS MEDICAL SYSTEMS, INC. SINGLE DOSE DISPENSING PIN, MODEL 2201 11/13/2001
K830836 ALLTEK FILTRATION, INC. Q.C. TESTER 04/18/1983
K843639 AMERICAN MCGAW ADD-A-VIAL SOLUTION TRANSFER DEVICE 01/14/1985
K812928 AMERICAN PHARMASEAL DIV. AHSC VACU-FIL TRANSFER SET 12/30/1981
K012189 ANGIPLAST PRIVATE LTD. ANGELTOUCH VENTED IV ADMINISTRATION SET 03/05/2002
K151423 B. BRAUN MEDICAL INC. APEX Compounding System Transfer Set 02/19/2016
K150787 B. Braun Medical Inc. Universal Spike 12/02/2015
K100640 B. BRAUN MEDICAL, INC. 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 07/22/2010
K090905 B. BRAUN MEDICAL, INC. ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE 04/27/2009
K970359 B. BRAUN MEDICAL, INC. COMBIPROT EMERGENCY ENFUSION DEVICE 03/18/1997
K120150 B. BRAUN MEDICAL, INC. DUAL SPIKE TRANSFER DEVICE 05/24/2012
K955398 B. BRAUN MEDICAL, INC. FORMULATION PREPARATION DEVICE 04/04/1996
K041222 B. BRAUN MEDICAL, INC. PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET 10/14/2004
K983794 B. BRAUN OF AMERICA, INC. CHEMO MINI SPIKE PLUS 03/23/1999
K943181 B. BRAUN OF AMERICA, INC. DISPENSING PIN WITH ONE-WAY VALVE 09/29/1994
K925401 B. BRAUN OF AMERICA, INC. IV FLUID TRANSFER PIN 03/03/1993
K002705 BAXA CORP. EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 03/28/2001
K022523 BAXA CORP. RAPID-FILL TUBESET, MODEL 90005 08/12/2002
K090917 BAXA CORP. SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM 02/19/2010
K844904 BAXA CORP., SUB. OF COOK GROUP, INC. CYTOSAFE NEEDLE 02/22/1985
K832312 BAXA CORP., SUB. OF COOK GROUP, INC. I.V. TRANSFER NEEDLE 09/12/1983
K904225 BAXA CORP., SUB. OF COOK GROUP, INC. KWIKMIX 11/05/1990
K900585 BAXA CORP., SUB. OF COOK GROUP, INC. TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP 04/18/1990
K832347 BAXA CORP., SUB. OF COOK GROUP, INC. TWOFER NEEDLE 09/12/1983
K903159 BAXA CORP., SUB. OF COOK GROUP, INC. VALVE CONTROLLER FOR MICROMACRO COMPOUNDER 11/07/1990
K832332 BAXA CORP., SUB. OF COOK GROUP, INC. VENTED I.V. TRANSFER NEEDLE 09/12/1983
K894827 BAXTER HEALTHCARE CORP. AUTOMIX 3+3 COMPOUNDER 10/06/1989
K961008 BAXTER HEALTHCARE CORP. AUTOMIX 3+3/AS COMPOUNDER SYSTEM 10/10/1997
K955622 BAXTER HEALTHCARE CORP. AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM; 05/06/1997
K042410 BAXTER HEALTHCARE CORP. BAXJECT II 10/08/2004
K003730 BAXTER HEALTHCARE CORP. CHEMO-AIDE DISPENSING PIN 12/20/2000
K884626 BAXTER HEALTHCARE CORP. MODIFIED SLIDING RECONSTITUTION DEVICE 11/22/1988
K910793 BAXTER HEALTHCARE CORP. RECONSTITUTION DEVICE 03/21/1991
K852467 BAXTER HEALTHCARE CORP. VIAL VENT FILTER 10/17/1985
K973654 BAXTER HEALTHCARE CORP. VIAL-MATE RECONSTITUTION DEVICE (2B8071) 10/24/1997
K092318 BAXTER HEALTHCARE CORPORATION BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE 10/30/2009
K142600 BAXTER HEALTHCARE CORPORATION VIAL-MATE Adaptor 11/19/2014
K120384 BD MEDICAL-MEDICAL SURGICAL SYSTEMS PROTECTOR, INJECTOR, CONNECTOR 09/12/2012
K834500 BERLEX LABORATORIES, INC. SOLUTION TRANSFER SET 02/17/1984
K041564 BIOJECT MEDICAL TECHNOLOGIES INC. Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 07/16/2004
K043304 BIOJECT MEDICAL TECHNOLOGIES INC. Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 01/14/2005
K963012 BIOJECT, INC. BIOJECT NEEDLE-FREE VIAL ADAPTER (13MM) 10/15/1996
K010623 BIOJECT, INC. RECONSTITUTION KIT & VIAL CONNECTOR 04/05/2001
K052790 CARDINAL HEALTH, ALARIS PRODUCTS SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD 12/23/2005
K080174 CARDIOMED SUPPLIES, INC. PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C 04/23/2008
K110023 CARMEL PHARMA AB. INFUSION ADAPTER C100 04/12/2011
K092782 CARMEL PHARMA AB. INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, 12/07/2009
K023747 CARMEL PHARMA AB. PHASEAL 11/15/2002
K060866 CARMEL PHARMA AB. PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS 04/28/2006
K090634 CARMEL PHARMA AB. PHASEAL PROTECTOR P14, P21, P28 AND P50 03/23/2009
K980381 CARMEL PHARMA AB. PHASEAL, CLOSED SYSTEM FORHANDLING OF PARENTERAL DRUGS, ADDITIONAL ADMINISTRATION DEVICES. C80 INFUSION ADAPTER, A10 PRO 03/03/1998
K001368 CARMEL PHARMA AB. PROTECTOR 21, PROTECTOR 50, PROTECTOR 14, INJECTOR LUER LOCK, INFUSION ADAPTER 05/12/2000
K861434 CHURCHILL CORP. MODIFIED HC-417 BAG TO BAG & HC-418 BOTTLE TO BAG 05/01/1986
K974198 CLINICO TAKY-SPIKE PLUS 12/22/1997
K960921 CODAN MEDLON, INC. CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE 04/17/1996
K830970 CODAN TRADING CO. DOUBLE LUMEN TRANSFER DEVICE 04/12/1983
K990711 CODAN US CORP. CODAN CHEMOSPIKE 04/13/1999
K860703 CORNING COSTAR CORP. U - STAR (MICRO-STAR) 05/06/1986
K964989 CRITICAL DEVICE CORP. CDC VIAL AND BAG ACCESS PIN (CDC-P-1/P-2/P-3/P-4/P-5) 04/02/1997
K955896 CRITICAL DEVICE CORP. MACROBORE TUBING - CDC-F-1 THROUGH CDC-F-11 02/06/1996
K926071 DAVID BULL LABORATORIES, USA, INC. ONCO-VIAL ADAPTER 02/14/1994
K133097 DUOJECT MEDICAL SYSTEMS, INC. E-Z LINK 03/13/2014
K010703 DUOJECT MEDICAL SYSTEMS, INC. INTER-VIAL 06/25/2001
K070584 DUOJECT MEDICAL SYSTEMS, INC. SMART-ROD 04/02/2008
K921031 EDGEWATER MEDICAL CENTER EDGE MEDICAL DISPENSING PIN 10/19/1992
K101940 EQUASHIELD MEDICAL LTD EQUASHIELD SYSTEM PROTECTIVE PLUS 11/19/2010
K000367 EUROSPITAL SECURMIX 02/29/2000
K913804 EXCEL MEDICAL, INC. EXCELSIOR SINGLE LEAD DISPENSING SET 02/11/1992
K905116 EXCEL MEDICAL, INC. PHARM-ASSIST 04/25/1991
K923966 EXCEL MEDICAL, INC. SYRINGE ADAPTOR 06/18/1993
K932462 EXCEL MEDICAL, INC. VENTED NEEDLE 09/15/1993
K101309 EXELINT INTERNATIONAL CO. EXELINT ALUMINUM HUB BLUNT NEEDLES 10/20/2010
K970789 FAULDING MEDICAL DEVICE CO. SAFE-CONNECT VIAL DISPENSING SPIKE 05/01/1997
K902853 FERGY CORP. GRAVITY PLUS CONTROLLER/COMPOUNDER 05/09/1991
K041232 GETTIG PHARMACEUTICAL INSTRUMENT CO. GETTIG UNIVERSAL VIAL ACCESS PIN 07/22/2004
K040634 HALKEY-ROBERTS CORP. ROBERTSITE VIAL ADAPTER, MODEL 245700021 03/23/2004
K860610 HEALTHTEK, INC. ADCOMP 07/08/1986
K874495 HEALTHTEK, INC. ADCOMP 4000 HP SYSTEM 02/16/1988
K854008 HEALTHTEK, INC. STATLOCK 11/13/1985
K913985 HEALTHTEK, INC. TRANSFER-AID(TM) 03/18/1992
K133602 HOSPIRA, INC. ADD-VANTAGE ADDAPTOR 01/24/2014
K980587 INRAD IV DECANTER-FLEXIBLE 04/17/1998
K872446 INSTAFIL, INC. MODIFIED INSTAFIL 08/25/1987
K173577 International Medical Industries Inc. Guarded Luer Connector 06/07/2018
K860434 INTL. MEDICAL INDUSTRIES CHEMO-VENT 02/12/1986
K850051 INTL. MEDICAL INDUSTRIES VERSA-FILL 120 & FILL SET 42-50 03/06/1985
K083851 INVIRO MEDICAL DEVICES, INC. INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 05/15/2009
K994323 KAWASUMI LABORATORIES CO., LTD. KAWASUMI LABORATORIES PHILEBOTOMY SET 03/08/2000
K904855 KENDALL MCGAW LABORATORIES, INC. ADD-A-VIAL 11/19/1990
K900865 KENDALL MCGAW LABORATORIES, INC. ADD-A-VIAL II BINARY CONNECTOR 07/11/1990
K152441 KIRO ROBOTICS S.L. KIRO Set 12/04/2015
K102590 LABORATORIOS GRIFOLS, S.A. FLEBOSET DOUBLE 01/13/2011
K040456 LABORATORIOS GRIFOLS, S.A. FLEBOSET MULTIPLE 03/09/2004
K162216 LABORATORIOS GRIFOLS, S.A. GRI-FILL PERISTALTIC SET 10/19/2017
K082752 LABORATORIOS GRIFOLS, S.A. QUICKPIN 09/29/2008
K033682 LABORATORIOS GRIFOLS, S.A. SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE 12/17/2003
K093182 LABORATORIOS GRIFOLS, S.A. SET GRI-FILL 3.0 01/27/2010
K050339 LABORATORIOS GRIFOLS, S.A. SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE 02/25/2005
K842345 LYPHOMED, INC. MAXIFILL TRANSFER SET 08/17/1984
K852882 LYPHOMED, INC. MAXIFILL TRANSFER SET 08/16/1985
K955594 MCGAW, INC. SAFELINE I.V. BAG ACCESS DEVICE 03/06/1996
K955595 MCGAW, INC. SAFELINE MULTIDOSE VIAL ADAPTER 03/06/1996
K905201 MCGAW, INC. TPN FLUID TRANSFER SET 01/02/1991
K974431 MEDI-DOSE, INC. CHEMO-SPIKE II RECONSTITUTION DEVICE 01/08/1998
K972117 MEDICAL SPECIALTY INNOVATIONS, INC. (MSI) MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW 08/26/1997
K860113 MEDIMIX PRODUCTS, INC. DOUBLE-JECT TRANSFER NEEDLE 02/12/1986
K171796 Medimop Medical Project Ltd. Vial Adapter 15mm 10/12/2017
K170095 Medimop Medical Project Ltd. Vial2Bag Direct Connect 03/08/2017
K160503 MEDIMOP MEDICAL PROJECTS LTD. Vented Vial Adapter Transfer Device - 13mm 05/04/2016
K031861 MEDIMOP MEDICAL PROJECTS, LTD. MIX2VIAL TRANSFER DEVICE 07/29/2003
K963583 MEDIMOP MEDICAL PROJECTS, LTD. MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PREATTACHED NEEDLE 10/07/1996
K001293 MEDIMOP MEDICAL PROJECTS, LTD. MODIFICATION TO MIXJECT DISPENSING PIN/WITH DETACHABLE VIAL HOLDER/WITH DETACHABLE VIAL HOLDER AND PRE-ATTACHED NEEDLE 05/05/2000
K130179 MEDIMOP MEDICAL PROJECTS, LTD. MP VIAL ADAPTER 13MM 08/08/2013
K001831 MEDIMOP MEDICAL PROJECTS, LTD. NEEDLELESS TRANSFER DEVICE 07/11/2000
K072511 MEDIMOP MEDICAL PROJECTS, LTD. SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM 12/13/2007
K062482 MEDIMOP MEDICAL PROJECTS, LTD. VENTED VIAL ADAPTER TRANSFER DEVICE 11/03/2006
K132040 MEDIMOP MEDICAL PROJECTS, LTD. VIAL CONNECTOR 13MM CLOSED COLLAR 07/31/2013
K072759 MEDIMOP MEDICAL PROJECTS, LTD. VIAL2BAG 12/13/2007
K140730 MEDIMOP MEDICAL PROJECTS, LTD. VIAL2BAG DIRECT CONNECT 06/12/2014
K111577 MEDLINE INDUSTRIES, INC. MEDLINE VIAL DECANTER 09/08/2011
K853075 MEDNOVA CORP. MEDNOVA SAFETY BAG 10/16/1985
K140402 MEDSOURCE INTERNATIONAL, LLC. MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET 04/03/2014
K120424 MEDSOURCE INTERNATIONAL, LLC. MEDSOURCE IV ADMINSTRATION SET 07/11/2012
K140442 MEDSOURCE INTERNATIONAL, LLC. MEDSOURCE SELECTABLE IV SET 04/22/2014
K895922 METRIX CO. METRICARE EMPTY CONTAINER SYSTEMS 08/22/1990
K051669 MIGADA PLANT TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM 09/01/2005
K071741 MIGADA PLANT TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM 09/24/2007
K943095 MIGADA, LTD. IV TRANSFER SPIKE 09/30/1994
K860595 MIGADA, LTD. TRANSFER SET 04/07/1986
K080976 NEXUS MEDICAL, LLC NEXUS I.V. FLUID TRANSFER DEVICE 11/10/2008
K092246 NIPRO MEDICAL CORPORATION NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 11/12/2009
K935274 OHMEDA MEDICAL DIPRIVAN LUER CONNECTOR 03/15/1994
K923782 PACIFIC DEVICE, INC. TRANSFER SET 07/02/1993
K902482 PACIFIC DEVICE, INC. VITALMIX (SET & BAG) 07/02/1990
K161800 PHARMC, LLC OnSite-IV 12/06/2016
K091389 PLASTMED, LTD. EQUALSHIELD LUER LOCK CONNECTOR PAIR 10/22/2009
K083152 PLASTMED, LTD. EQUASHIELD SYSTEM 02/02/2009
K935532 PURITAS HEALTH CARE, INC. TRANSFER SET 04/04/1994
K950305 Q.I. MEDICAL, INC. QTMICRO(TM) SYSTEM 10/13/1995
K920015 Q.I. MEDICAL, INC. QUICKTEST SYSTEM 11/23/1992
K972134 REMINGTON MEDICAL, INC. BAG DECANTER 08/26/1997
K131646 SHANGHAI JINTA MEDICAL CO., LTD DISPOSABLE INFUSION SET 11/26/2013
K013523 SHIRE BIOLOGICS INC. CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 01/07/2002
K854556 SOMA INTL., INC. TRANSFER NEEDLE 01/16/1986
K890204 STEDIM, INC. AUTOMIX COMPOUNDER VENTED SPIKE ADAPTOR 10/27/1989
K890205 STEDIM, INC. AUTOMIX COMPOUNDER Y - ADAPTOR SET 10/27/1989
K853830 TRAVENOL LABORATORIES, S.A. SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST 11/06/1985
K844340 TRAVENOL LABORATORIES, S.A. TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP 01/09/1985
K023539 VALUMED STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW 12/17/2002
K041691 WEST PHARMACEUTICAL SERVICES, INC. CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT 08/05/2004
K172884 Yukon Medical Arisure Closed Vial Adapter 10/03/2017
K172631 Yukon Medical Arisure Dry Spike 09/29/2017
K151963 YUKON MEDICAL, LLC SmartSite Vented Vial Access Device 07/31/2015
K132863 YUKON MEDICAL, LLC SMARTSITE VIALSHIELD 10/04/2013
K121182 YUKON MEDICAL, LLC VIALOK NON-VENTED 05/03/2012
K122265 YUKON MEDICAL, LLC VIALOK SINGLE VIAL ACCESS DEVICE VENTED 08/14/2012


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