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 |
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 |
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 |
K222718 |
Hangzhou Qiantang Longyue Biotechnology Co., LTD |
Vial Adapter |
03/10/2023 |
K133602 |
HOSPIRA, INC. |
ADD-VANTAGE ADDAPTOR |
01/24/2014 |
K192154 |
ICU Medical |
Rio Vial-to-Bag Drug Reconstitution Device |
04/20/2020 |
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 |
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 |
K023539 |
VALUMED |
STERI-SPOUTS; BAG-SPOUT, VIAL-SPOUT, TRANSFER MIXER; RAPIDFLOW, VIALFLOW, TRANSFLOW |
12/17/2002 |
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 |
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 |
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 |