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 |
| K212525 | Advcare Medical | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | 08/19/2022 |
| K203674 | AEA srl | B Dispensing Line | 09/27/2021 |
| K013087 | ALARIS MEDICAL SYSTEMS, INC. | SINGLE DOSE DISPENSING PIN, MODEL 2201 | 11/13/2001 |
| K012189 | ANGIPLAST PRIVATE LTD. | ANGELTOUCH VENTED IV ADMINISTRATION SET | 03/05/2002 |
| K232987 | Asset Medikal Tasarim Sanayi Ve Ticaret A.S. | FlowArt Valve for Vial Access | 06/26/2024 |
| K190149 | Avenir Performance Europeenne Medical (APEM) | Vial Adapter ╪20 mm | 10/15/2019 |
| K190816 | Avenir Performance Europeenne Medical (APEM) | Vial Adapter ╪20 mm , Vial Adapter ╪13 mm | 11/19/2019 |
| K220856 | Avenir Performance EuropΘenne Medical (APEM) | Vial Adapter ╪13mm | 06/21/2022 |
| K151423 | B. BRAUN MEDICAL INC. | APEX Compounding System Transfer Set | 02/19/2016 |
| K201469 | B. Braun Medical Inc. | Mini Spike Plus 6/8R | 12/09/2020 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K233021 | CareFusion | BD SmartSiteÖ 13mm Vial Access Device; BD SmartSiteÖ 20mm Vial Access Device | 03/06/2024 |
| 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 |
| K974198 | CLINICO | TAKY-SPIKE PLUS | 12/22/1997 |
| K960921 | CODAN MEDLON, INC. | CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE | 04/17/1996 |
| K990711 | CODAN US CORP. | CODAN CHEMOSPIKE | 04/13/1999 |
| 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 |
| 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 |
| K101940 | EQUASHIELD MEDICAL LTD | EQUASHIELD SYSTEM PROTECTIVE PLUS | 11/19/2010 |
| K000367 | EUROSPITAL | SECURMIX | 02/29/2000 |
| 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 |
| K212445 | Fresenius Kabi AG | freeflex+ Transfer Adapter | 06/01/2022 |
| K182819 | Gcmedica Enterprise Ltd., (WUXI) | Decanting Device | 12/02/2019 |
| 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 |
| K233287 | Hangzhou Qiantang Longyue Biotechnology Co., Ltd | Vent Vial Adapter | 07/26/2024 |
| K222718 | Hangzhou Qiantang Longyue Biotechnology Co., LTD | Vial Adapter | 03/10/2023 |
| K233284 | Hangzhou Qiantang Longyue Biotechnology Co., Ltd | Vial Adapter with Filter | 05/01/2024 |
| K133602 | HOSPIRA, INC. | ADD-VANTAGE ADDAPTOR | 01/24/2014 |
| K192154 | ICU Medical | Rio Vial-to-Bag Drug Reconstitution Device | 04/20/2020 |
| K243985 | ICU Medical, Inc. | RioÖ Drug Reconstitution Transfer Device | 01/22/2025 |
| K980587 | INRAD | IV DECANTER-FLEXIBLE | 04/17/1998 |
| K173577 | International Medical Industries Inc. | Guarded Luer Connector | 06/07/2018 |
| K083851 | INVIRO MEDICAL DEVICES, INC. | INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 | 05/15/2009 |
| K200893 | IPAX, Inc | ProntoPump Sterile Tube Set | 05/04/2021 |
| K221406 | Jiangsu Caina Medical Co., Ltd. | Vented Vial Transfer Pin | 10/28/2022 |
| K994323 | KAWASUMI LABORATORIES CO., LTD. | KAWASUMI LABORATORIES PHILEBOTOMY SET | 03/08/2000 |
| 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 |
| K955594 | MCGAW, INC. | SAFELINE I.V. BAG ACCESS DEVICE | 03/06/1996 |
| K955595 | MCGAW, INC. | SAFELINE MULTIDOSE VIAL ADAPTER | 03/06/1996 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K212530 | Omnicell, Inc. | IVX Fluid Transfer Set | 04/24/2022 |
| 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 |
| K972134 | REMINGTON MEDICAL, INC. | BAG DECANTER | 08/26/1997 |
| K183187 | SFM Medical Devices GmbH | nextaro Transfer System, nextaro va | 03/15/2019 |
| K240748 | sfm medical devices GmbH | nextaro« v, 20/20 | 04/16/2024 |
| K241976 | SFM Medical Devices GmbH | nextaro« va, 15mm, 5╡m | 09/06/2024 |
| K131646 | SHANGHAI JINTA MEDICAL CO., LTD | DISPOSABLE INFUSION SET | 11/26/2013 |
| K232055 | Shanghai Ling Fu Technology Co., Ltd. | Vial Adapter | 10/06/2023 |
| K013523 | SHIRE BIOLOGICS INC. | CISTEM FLUID TRANSFER DEVICE, MODEL 7S2012 AND 7S2013 | 01/07/2002 |
| K202732 | Sol-Millennium Medical Group | SOL-CARE IV Bag Safety Connector | 11/03/2021 |
| K243404 | Takeda Pharmaceuticals | HyHubÖ and HyHubÖ Duo Vial Access Devices | 07/18/2025 |
| K023539 | VALUMED | STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW | 12/17/2002 |
| K231071 | West Pharma Services IL, Ltd. | Mix2Vial« Transfer Device | 01/19/2024 |
| K230464 | West Pharma Services IL, Ltd. | MixJect« Transfer Device | 05/22/2023 |
| K213513 | West Pharma Services IL, Ltd. | Vented Vial Adapter 20mm | 08/31/2022 |
| K232875 | West Pharma Services IL, Ltd. | Vial Adapter 20mm | 12/14/2023 |
| K230988 | West Pharma Services IL, Ltd. | Vial2Bag Advanced« 13mm Admixture Device | 12/01/2023 |
| K201415 | West Pharmaceutical Services AZ, Inc. | Vial2Bag Advanced 20mm Admixture Device | 10/21/2020 |
| K041691 | WEST PHARMACEUTICAL SERVICES, INC. | CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT | 08/05/2004 |
| K240940 | West Pharmaceutical Services, Inc. | Vial2Bag Advanced« 20mm Admixture Device | 05/03/2024 |
| K172884 | Yukon Medical | Arisure Closed Vial Adapter | 10/03/2017 |
| K172631 | Yukon Medical | Arisure Dry Spike | 09/29/2017 |
| K240761 | Yukon Medical, LLC | Arisure« Closed Male Luer with Spike Adapter (YM060) | 03/21/2025 |
| K151963 | YUKON MEDICAL, LLC | SmartSite Vented Vial Access Device | 07/31/2015 |
| K132863 | YUKON MEDICAL, LLC | SMARTSITE VIALSHIELD | 10/04/2013 |
| K243486 | Yukon Medical, LLC | SmartSiteTM Vented Vial Access Device | 12/06/2024 |
| 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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