FDA Product Code
FDA Product Code LHI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5440
510(k) Clearances — 206 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252987 | ADRx Admixture Device | Epic Medical Pte. , Ltd. | 2026-06-12 | Traditional | PDF ↗ |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 | Traditional | PDF ↗ |
| K250345 | Medline Bag Decanter | Medline Industries, LP | 2025-10-24 | Traditional | PDF ↗ |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | 2025-10-14 | Traditional | PDF ↗ |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | 2025-09-16 | Traditional | PDF ↗ |
| K243404 | HyHub and HyHub Duo Vial Access Devices | Takeda Pharmaceuticals | 2025-07-18 | Traditional | PDF ↗ |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 | Traditional | PDF ↗ |
| K243985 | Rio Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 | Traditional | PDF ↗ |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024-12-06 | Traditional | PDF ↗ |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024-09-06 | Special | PDF ↗ |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 | Traditional | PDF ↗ |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 | Traditional | PDF ↗ |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 | Special | PDF ↗ |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 | Traditional | PDF ↗ |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024-04-16 | Special | PDF ↗ |
| K233021 | BD SmartSite 13mm Vial Access Device; BD SmartSite 20mm Vial Access Device | Care Fusion | 2024-03-06 | Traditional | PDF ↗ |
| K231071 | Mix2Vial® Transfer Device | West Pharma. Services IL, Ltd. | 2024-01-19 | Traditional | PDF ↗ |
| K232875 | Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2023-12-14 | Traditional | PDF ↗ |
| K230988 | Vial2Bag Advanced® 13mm Admixture Device | West Pharma. Services IL, Ltd. | 2023-12-01 | Traditional | PDF ↗ |
| K232055 | Vial Adapter | Shanghai Lingfu Technology Co., Ltd. | 2023-10-06 | Traditional | PDF ↗ |
| K230464 | MixJect® Transfer Device | West Pharma. Services IL, Ltd. | 2023-05-22 | Traditional | PDF ↗ |
| K222718 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2023-03-10 | Traditional | PDF ↗ |
| K213513 | Vented Vial Adapter 20mm | West Pharma. Services IL, Ltd. | 2022-08-31 | Traditional | PDF ↗ |
| K212525 | Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices | Advcare Medical | 2022-08-19 | Traditional | PDF ↗ |
| K220856 | Vial Adapter Ø13mm | Avenir Performance Européenne Medical (Apem) | 2022-06-21 | Traditional | PDF ↗ |
| K212445 | freeflex+ Transfer Adapter | Fresenius Kabi AG | 2022-06-01 | Traditional | PDF ↗ |
| K212530 | IVX Fluid Transfer Set | Omnicell, Inc. | 2022-04-24 | Traditional | PDF ↗ |
| K202732 | SOL-CARE IV Bag Safety Connector | Sol-Millennium Medical Group | 2021-11-03 | Traditional | PDF ↗ |
| K203674 | B Dispensing Line | Aea Srl | 2021-09-27 | Traditional | PDF ↗ |
| K200893 | ProntoPump Sterile Tube Set | Ipax, Inc. | 2021-05-04 | Traditional | PDF ↗ |
| K201469 | Mini Spike Plus 6/8R | B.Braun Medical, Inc. | 2020-12-09 | Traditional | PDF ↗ |
| K201415 | Vial2Bag Advanced 20mm Admixture Device | West Pharmaceutical Services Az, Inc. | 2020-10-21 | Traditional | PDF ↗ |
| K192154 | Rio Vial-to-Bag Drug Reconstitution Device | Icu Medical | 2020-04-20 | Traditional | PDF ↗ |
| K182819 | Decanting Device | Gcmedica Enterprise Ltd.(Wuxi) | 2019-12-02 | Traditional | PDF ↗ |
| K190816 | Vial Adapter Ø20 mm , Vial Adapter Ø13 mm | Avenir Performance Europeenne Medical (Apem) | 2019-11-19 | Traditional | PDF ↗ |
| K190149 | Vial Adapter Ø20 mm | Avenir Performance Europeenne Medical (Apem) | 2019-10-15 | Traditional | PDF ↗ |
| K183187 | nextaro Transfer System, nextaro va | Sfm Medical Devices GmbH | 2019-03-15 | Traditional | PDF ↗ |
| K173577 | Guarded Luer Connector | International Medical Industries, Inc. | 2018-06-07 | Traditional | PDF ↗ |
| K162216 | GRI-FILL PERISTALTIC SET | Laboratorios Grifols, S.A. | 2017-10-19 | Abbreviated | PDF ↗ |
| K171796 | Vial Adapter 15mm | Medimop Medical Project , Ltd. | 2017-10-12 | Special | PDF ↗ |
| K172884 | Arisure Closed Vial Adapter | Yukon Medical | 2017-10-03 | Traditional | PDF ↗ |
| K172631 | Arisure Dry Spike | Yukon Medical | 2017-09-29 | Traditional | PDF ↗ |
| K170095 | Vial2Bag Direct Connect | Medimop Medical Project , Ltd. | 2017-03-08 | Special | PDF ↗ |
| K161800 | OnSite-IV | Pharmc, LLC | 2016-12-06 | Traditional | PDF ↗ |
| K160503 | Vented Vial Adapter Transfer Device - 13mm | Medimop Medical Projects, Ltd. | 2016-05-04 | Special | PDF ↗ |
| K151423 | APEX Compounding System Transfer Set | B.Braun Medical, Inc. | 2016-02-19 | Traditional | PDF ↗ |
| K152441 | KIRO Set | Kiro Robotics S.L. | 2015-12-04 | Traditional | PDF ↗ |
| K150787 | Universal Spike | B.Braun Medical, Inc. | 2015-12-02 | Traditional | PDF ↗ |
| K151963 | SmartSite Vented Vial Access Device | Yukon Medical, LLC | 2015-07-31 | Traditional | PDF ↗ |
| K142600 | VIAL-MATE Adaptor | Baxter Healthcare Corporation | 2014-11-19 | Special | PDF ↗ |
| K140730 | VIAL2BAG DIRECT CONNECT | Medimop Medical Projects, Ltd. | 2014-06-12 | Traditional | PDF ↗ |
| K140442 | MEDSOURCE SELECTABLE IV SET | Medsource International, LLC | 2014-04-22 | Special | PDF ↗ |
| K140402 | MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET | Medsource International, LLC | 2014-04-03 | Special | PDF ↗ |
| K133097 | E-Z LINK | Duoject Medical Systems, Inc. | 2014-03-13 | Traditional | PDF ↗ |
| K133602 | ADD-VANTAGE ADDAPTOR | Hospira, Inc. | 2014-01-24 | Traditional | PDF ↗ |
| K131646 | DISPOSABLE INFUSION SET | Shanghai Jinta Medical Co., Ltd. | 2013-11-26 | Traditional | PDF ↗ |
| K132863 | SMARTSITE VIALSHIELD | Yukon Medical, LLC | 2013-10-04 | Traditional | PDF ↗ |
| K130179 | MP VIAL ADAPTER 13MM | Medimop Medical Projects, Ltd. | 2013-08-08 | Traditional | PDF ↗ |
| K132040 | VIAL CONNECTOR 13MM CLOSED COLLAR | Medimop Medical Projects, Ltd. | 2013-07-31 | Special | PDF ↗ |
| K120384 | PROTECTOR, INJECTOR, CONNECTOR | Bd Medical-Medical Surgical Systems | 2012-09-12 | Traditional | PDF ↗ |
| K122265 | VIALOK SINGLE VIAL ACCESS DEVICE VENTED | Yukon Medical, LLC | 2012-08-14 | Traditional | PDF ↗ |
| K120424 | MEDSOURCE IV ADMINSTRATION SET | Medsource International, LLC | 2012-07-11 | Traditional | PDF ↗ |
| K120150 | DUAL SPIKE TRANSFER DEVICE | B.Braun Medical, Inc. | 2012-05-24 | Traditional | PDF ↗ |
| K121182 | VIALOK NON-VENTED | Yukon Medical, LLC | 2012-05-03 | Traditional | PDF ↗ |
| K111577 | MEDLINE VIAL DECANTER | Medline Industries, Inc. | 2011-09-08 | Traditional | PDF ↗ |
| K110023 | INFUSION ADAPTER C100 | Carmel Pharma Ab. | 2011-04-12 | Traditional | PDF ↗ |
| K102590 | FLEBOSET DOUBLE | Laboratorios Grifols, S.A. | 2011-01-13 | Abbreviated | PDF ↗ |
| K101940 | EQUASHIELD SYSTEM PROTECTIVE PLUS | Equashield Medical , Ltd. | 2010-11-19 | Traditional | PDF ↗ |
| K101309 | EXELINT ALUMINUM HUB BLUNT NEEDLES | Exelint International, Co. | 2010-10-20 | Traditional | PDF ↗ |
| K100640 | 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 | B.Braun Medical, Inc. | 2010-07-22 | Traditional | PDF ↗ |
| K090917 | SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Baxa Corp. | 2010-02-19 | Traditional | PDF ↗ |
| K093182 | SET GRI-FILL 3.0 | Laboratorios Grifols, S.A. | 2010-01-27 | Abbreviated | PDF ↗ |
| K092782 | INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35, | Carmel Pharma Ab. | 2009-12-07 | Traditional | PDF ↗ |
| K092246 | NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 | Nipro Medical Corporation | 2009-11-12 | Traditional | PDF ↗ |
| K092318 | BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE | Baxter Healthcare Corporation | 2009-10-30 | Traditional | PDF ↗ |
| K091389 | EQUALSHIELD LUER LOCK CONNECTOR PAIR | Plastmed, Ltd. | 2009-10-22 | Special | PDF ↗ |
| K083851 | INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 | Inviro Medical Devices, Inc. | 2009-05-15 | Special | PDF ↗ |
| K090905 | ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE | B.Braun Medical, Inc. | 2009-04-27 | Special | PDF ↗ |
| K090634 | PHASEAL PROTECTOR P14, P21, P28 AND P50 | Carmel Pharma Ab. | 2009-03-23 | Special | PDF ↗ |
| K083152 | EQUASHIELD SYSTEM | Plastmed, Ltd. | 2009-02-02 | Traditional | PDF ↗ |
| K080976 | NEXUS I.V. FLUID TRANSFER DEVICE | Nexus Medical, LLC | 2008-11-10 | Traditional | PDF ↗ |
| K082752 | QUICKPIN | Laboratorios Grifols, S.A. | 2008-09-29 | Traditional | PDF ↗ |
| K080174 | PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C | Cardio Med Supplies, Inc. | 2008-04-23 | Traditional | PDF ↗ |
| K070584 | SMART-ROD | Duoject Medical Systems, Inc. | 2008-04-02 | Traditional | PDF ↗ |
| K072511 | SWABABLE VIAL ADAPTER 13MM, SWABABLE VIAL ADAPTER 20MM | Medimop Medical Projects, Ltd. | 2007-12-13 | Abbreviated | PDF ↗ |
| K072759 | VIAL2BAG | Medimop Medical Projects, Ltd. | 2007-12-13 | Abbreviated | PDF ↗ |
| K071741 | TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Migada Plant | 2007-09-24 | Traditional | PDF ↗ |
| K062482 | VENTED VIAL ADAPTER TRANSFER DEVICE | Medimop Medical Projects, Ltd. | 2006-11-03 | Traditional | PDF ↗ |
| K060866 | PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS | Carmel Pharma Ab. | 2006-04-28 | Special | PDF ↗ |
| K052790 | SMARTSITE VENTED VIAL ACCESS DEVICE, MODEL TBD | Cardinal Health, Alaris Products | 2005-12-23 | Traditional | PDF ↗ |
| K051669 | TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM | Migada Plant | 2005-09-01 | Traditional | PDF ↗ |
| K050339 | SET GRI-FILL 3.0-1 WAY, 2 WAYS, MULTIPLE | Laboratorios Grifols, S.A. | 2005-02-25 | Traditional | PDF ↗ |
| K043304 | Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 | Bioject Medical Technologies, Inc. | 2005-01-14 | Traditional | PDF ↗ |
| K041222 | PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET | B.Braun Medical, Inc. | 2004-10-14 | Traditional | PDF ↗ |
| K042410 | BAXJECT II | Baxter Healthcare Corp | 2004-10-08 | Abbreviated | PDF ↗ |
| K041691 | CLIP 'N'JECT RECONSTITUTION SYSTEM (CLIP 'N'JECT | West Pharmaceutical Services, Inc. | 2004-08-05 | Traditional | PDF ↗ |
| K041232 | GETTIG UNIVERSAL VIAL ACCESS PIN | Gettig Pharmaceutical Instrument Co. | 2004-07-22 | Traditional | PDF ↗ |
| K041564 | Q-CAP NEEDLE-FREE RECONSTITUTION 13MM VIAL ADAPTER, MODEL 6100-01 | Bioject Medical Technologies, Inc. | 2004-07-16 | Traditional | PDF ↗ |
| K040634 | ROBERTSITE VIAL ADAPTER, MODEL 245700021 | Halkey-Roberts Corp. | 2004-03-23 | Traditional | PDF ↗ |
| K040456 | FLEBOSET MULTIPLE | Laboratorios Grifols, S.A. | 2004-03-09 | Traditional | PDF ↗ |
Product code LHI · Class II · General Hospital. Data: openFDA.