FDA 510(k) Applications for Medical Device Product Code "JKA"
(Tubes, Vials, Systems, Serum Separators, Blood Collection)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K062932 | AHLSTROM MOUNT HOLLY SPRINGS LLC | AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER | 10/19/2007 |
| K030815 | AKERS LABORATORIES, INC. | AKERS LABORATORIES INC. BLOOD CELL SEPARATOR | 09/17/2003 |
| K964698 | ANDWIN SCIENTIFIC | SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT | 03/03/1997 |
| K223323 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Blood Collection Needle (with/without Needle Holder) | 03/24/2023 |
| K222141 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Safety Blood Collection Needle (Without Needle Holder) | 10/21/2022 |
| K220900 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Safety Blood Collection Needles with/without Needle Holder | 08/10/2022 |
| K202188 | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Safety Blood Collection Sets for Single Use | 02/19/2021 |
| K220258 | AVIA Vascular | 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) | 07/14/2022 |
| K965202 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET | 02/10/1997 |
| K980414 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET | 03/03/1998 |
| K991551 | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC | VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE | 09/23/1999 |
| K023075 | BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS | BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE | 11/25/2002 |
| K030573 | BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | 05/08/2003 |
| K093972 | BECTON DICKINSON & CO. | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 | 01/21/2010 |
| K022426 | BECTON DICKINSON & CO. | BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 | 08/08/2002 |
| K022130 | BECTON DICKINSON & CO. | BD VACUTAINER PLUS PST II TUBE | 07/29/2002 |
| K101502 | BECTON DICKINSON & CO. | BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 | 06/29/2010 |
| K013971 | BECTON DICKINSON & CO. | BD VACUTAINER SAFETY COAGULATION TUBE | 02/01/2002 |
| K023331 | BECTON DICKINSON & CO. | BD VACUTAINER SST II PLUS TUBES | 11/25/2002 |
| K041071 | BECTON DICKINSON & CO. | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 | 05/14/2004 |
| K022875 | BECTON DICKINSON & CO. | MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET | 09/11/2002 |
| K222478 | Becton Dickinson and Company | BD Vacutainer« Luer-LokÖ Access Device, BD Vacutainer« Blood Transfer Device | 03/10/2023 |
| K213953 | Becton Dickinson and Company | BD Vacutainer« Trace Element K2EDTA Tubes, BD Vacutainer« Trace Element Serum Tubes | 07/17/2023 |
| K091292 | BECTON DICKINSON AND COMPANY (BD) | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | 08/25/2009 |
| K230865 | Becton Dickinson Infusion Therapy Systems, Inc. | PIVOÖ Pro Needle-free Blood Collection Device | 09/28/2023 |
| K991702 | BECTON DICKINSON VACUTAINER SYSTEMS | MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578 | 07/28/1999 |
| K002456 | BECTON DICKINSON VACUTAINER SYSTEMS | MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992 | 11/02/2000 |
| K982922 | BECTON DICKINSON VACUTAINER SYSTEMS | VACUTAINER BRAND BLOOD COLLECTION SYRINGE | 09/22/1998 |
| K991120 | BECTON DICKINSON VACUTAINER SYSTEMS | VACUTAINER BRAND CTAD TUBE (MULTIPLE) | 05/19/1999 |
| K991088 | BECTON DICKINSON VACUTAINER SYSTEMS | VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION, SAFETY BLOOD COLLE | 05/28/1999 |
| K960250 | BECTON DICKINSON VACUTAINER SYSTEMS | VACUTAINER BRAND PLUS SERUM & SST TUBES | 03/29/1996 |
| K980098 | BECTON DICKINSON VACUTAINER SYSTEMS | VACUTAINER BRAND PRONTO NEEDLES HOLDER | 02/05/1998 |
| K981013 | BECTON DICKINSON VACUTAINER SYSTEMS | VACUTAINER PLUS TUBE WITH EDTA ANTICOAGULANT ANDD VACUTAINER PLUS SERUM TUBE | 06/17/1998 |
| K220212 | Becton, Dickinson and Company | BD Vacutainer« Push Button Blood Collection Set, BD Vacutainer« Push Button Blood Collection Set with Pre-Attached Holder | 03/24/2023 |
| K160657 | BECTON, DICKINSON AND COMPANY | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube | 09/23/2016 |
| K153309 | BECTON, DICKINSON AND COMPANY | BD Vacutainer UltraTouch Push Button Blood Collection Set | 02/12/2016 |
| K212724 | Becton, Dickinson and Company | BD Vacutainer UltraTouch Push Button Blood Collection Set | 02/04/2022 |
| K202446 | Becton, Dickinson, and Company | BD Preset Syringe & BD A-Line Syringe | 09/25/2020 |
| K133303 | BIO-ANALYSIS, INC. | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device | 11/19/2014 |
| K090737 | BIO-RAD LABORATORIES, INC. | HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI | 06/03/2009 |
| K030394 | BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING | FLUID SAMPLE RETRIEVAL SYSTEM | 10/27/2003 |
| K030076 | BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING | PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM | 07/07/2003 |
| K012221 | BIOSAFE LABORATORIES, INC. | SAFE AT HOME CHOLESTEROL PROFILE BLOOD COLLECTION AND TRANSPORT SYSTEM | 04/03/2002 |
| K201009 | CHIRANA T. Injecta | CHIRAVAC Blood Collection Needles | 07/21/2021 |
| K213690 | Eclipse Medcorp LLC | Eclipse Blood Collection Set | 10/26/2022 |
| K971220 | GREINER AMERICA, INC. | GREINER VACUETTE BLOOD COLLECTION TUBE | 06/04/1997 |
| K971236 | GREINER AMERICA, INC. | GREINER VACUETTE BLOOD COLLECTION TUBE | 05/12/1997 |
| K971239 | GREINER AMERICA, INC. | GREINER VACUETTE BLOOD COLLECTION TUBE | 05/12/1997 |
| K960860 | GREINER AMERICA, INC. | GREINER VACUETTE BLOOD COLLECTION TUBE E/EDTA K3 | 09/05/1996 |
| K960857 | GREINER AMERICA, INC. | GREINER VACUETTE BLOOD COLLECTION TUBE W/LITHIUM HEPARIN & GEL SEPARATOR | 08/30/1996 |
| K960858 | GREINER AMERICA, INC. | GREINER VACUTTE BLOOD COLLECTION TUBE W/ CLOT ACTIVATOR & GEL SEPARATOR | 08/30/1996 |
| K182078 | Greiner Bio-One NA Inc. | MiniCollect K2E K2EDTA Tubes | 01/25/2019 |
| K122687 | GREINER BIO-ONE NORTH AMERICA, INC. | BLOOD CULTURE HOLDER | 01/10/2013 |
| K063357 | GREINER BIO-ONE NORTH AMERICA, INC. | MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES | 07/10/2007 |
| K081929 | GREINER BIO-ONE NORTH AMERICA, INC. | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR | 12/16/2008 |
| K103041 | GREINER BIO-ONE NORTH AMERICA, INC. | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR | 11/09/2010 |
| K011699 | GREINER BIO-ONE VACUETTE NORTH AMERICA | VACUETTE EVACUATED BLOOD COLLECTION TUBES | 06/28/2001 |
| K023971 | GREINER BIO-ONE VACUETTE NORTH AMERICA | VACUETTE TRACE ELEMENTS TUBES | 01/27/2003 |
| K992244 | GREINER MEDITECH, INC. | GREINER MINICOLLECT COAGULATION BLOOD COLLECTION TUBE | 07/26/1999 |
| K982999 | GREINER MEDITECH, INC. | GREINER MINICOLLECT EDTA BLOOD COLLECTION TUBE | 10/16/1998 |
| K991843 | GREINER MEDITECH, INC. | GREINER MINICOLLECT LITHIUM HEPARIN GEL BLOOD COLLECTION TUBE | 06/25/1999 |
| K982998 | GREINER MEDITECH, INC. | GREINER MINICOLLECT SERUM GEL BLOOD COLLECTION TUBE | 10/21/1998 |
| K983952 | GREINER MEDITECH, INC. | GREINER VACUETTE BLOOD COLLECTION TUBE | 12/28/1998 |
| K974873 | GREINER MEDITECH, INC. | VACUETTE (MULTI-USE HOLDER) | 02/05/1998 |
| K002777 | GREINER VACUETTE NORTH AMERICA, INC. | VACUETTE WITH PPACK | 10/05/2000 |
| K093910 | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | 07/12/2010 |
| K063852 | HOME ACCESS HEALTH CORP. | ACCESSA CHOLESTEROL PANEL | 11/09/2007 |
| K061979 | IMMUNETECH CORPORATION | MODIFICATION TO MYALLERGY TEST | 09/22/2006 |
| K021698 | IMMUNETECH CORPORATION | MY ALLERGY TEST | 09/19/2002 |
| K030596 | IMMUNICON CORP. | IMMUNICON CELLSAVE PRESERVATIVE TUBE | 08/08/2003 |
| K123987 | INNOVATIVE MEDICAL TECHNOLOGIES, INC. | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET | 08/27/2013 |
| K220458 | Innovative Medical Technologies, Inc. | UltraFlo-R Push Button Blood Collection Set | 09/29/2023 |
| K000777 | ITL CORPORATION, PTY LTD. | SAMPLOK | 04/11/2000 |
| K021941 | ITL CORPORATION, PTY LTD. | SAMPLOK LUER KIT | 07/02/2002 |
| K200027 | Jiangsu Caina Medical Co., Ltd. | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | 09/09/2020 |
| K222834 | Jiangsu Caina Medical Co.,Ltd | Safety Push Button Blood Collection Set | 01/05/2023 |
| K212019 | Jiangsu Micsafe Medical Technology Co., Ltd | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Colle | 11/04/2021 |
| K190485 | Kawasumi Laboratories, Inc. | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | 07/08/2019 |
| K191832 | Kurin, Inc | Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) | 02/04/2020 |
| K181895 | Kurin, Inc | Kurin PIV Blood Collection Set with High Pressure | 01/18/2019 |
| K220677 | Kurin, Inc, | Kurin Blood Culture Collection Set with Kurin Lock Technology | 04/28/2023 |
| K222299 | Magnolia Medical Technologies | Steripath Micro Blood Collection System | 11/30/2022 |
| K192247 | Magnolia Medical Technologies, Inc. | Steripath Gen2 Blood Collection System | 02/28/2020 |
| K120490 | NIPRO MEDICAL CORPORATION | QUICK SAMPLER HOLDER | 12/27/2012 |
| K193074 | NSP Tech Pte Ltd | Bevel Up Holder | 04/21/2020 |
| K181754 | NSP Tech Pte Ltd | Blood Collection Accessory (BUCA) | 07/30/2019 |
| K181743 | NSP Tech Pte Ltd | Blood Transfer Accessory (BTA) | 07/30/2019 |
| K974374 | OHMEDA MEDICAL | SAFE NEEDLE DIRECT BLOOD TRANSFER DEVICE, MODEL TA-STV | 01/02/1998 |
| K993787 | OSBORN GROUP, INC. | APPRAISE-CARDIO SAMPLE COLLECTION KIT | 04/14/2000 |
| K223854 | Owen Mumford Ltd | Unistik« ShieldLock, Unistik VacuFlip | 06/30/2023 |
| K162233 | Pathway LLC | Kurin Blood Culture Collection Set | 12/23/2016 |
| K962158 | RADIOMETER AMERICA, INC. | PICO MODELS 30, 50, 70 | 10/29/1996 |
| K043143 | RADIOMETER MEDICAL APS | SAFEPICO | 04/22/2005 |
| K981973 | RAM SCIENTIFIC | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM | 09/03/1998 |
| K983517 | RAM SCIENTIFIC | SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM | 11/12/1998 |
| K202325 | Retractable Technologies, Inc. | EasyPoint Blood Collection Plus | 04/09/2021 |
| K122355 | RETRACTABLE TECHNOLOGIES, INC. | VANISHPOINT BLOOD COLLECTION SET | 08/23/2013 |
| K051019 | SARSTEDT, INC. | SAFETY NEEDLE | 07/25/2005 |
| K220799 | SB-Kawasumi Laboratories, Inc. | K-SHIELD Zen | 08/29/2022 |
| K230408 | SB-Kawasumi Laboratories, Inc. | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | 06/01/2023 |
| K223810 | SB-Kawasumi Laboratories, Inc. | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | 02/24/2023 |
| K981035 | SIMS PORTEX, INC. | PRO-VENT, PULSATOR ARTERIAL BLOOD SAMPLING SYRINGES | 04/21/1998 |
| K962931 | SMITHS INDUSTRIES MEDICAL SYSTEMS, INC. | SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT | 10/21/1996 |
| K072783 | SMITHS MEDICAL ASD, INC. | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH | 11/30/2007 |
| K081229 | SMITHS MEDICAL ASD, INC. | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING | 07/21/2008 |
| K163073 | Sol-Millennium Medical, Inc. | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | 05/19/2017 |
| K213718 | Sol-Millennium Medical, Inc. | SOL-GUARD Safety Pull Button Collection Set | 08/30/2022 |
| K040107 | STRECK LABORATORIES, INC. | CYTO-CHEX BCT | 07/27/2004 |
| K936240 | SUDORMED, INC. | SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE) | 03/19/1996 |
| K060364 | TECO DIAGNOSTICS | VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE | 06/15/2006 |
| K983490 | TERUMO CORP. | TERUMO VENOJECT,LUER ADAPTER | 11/30/1998 |
| K041358 | TERUMO EUROPE N.V. | VENOJECT LUER ADAPTER | 05/28/2004 |
| K971111 | TRI-TECH, INC. | TRI-TECH INC., EVACUATED BLOOD COLLECTION TUBE, GRAY STOPPER | 06/16/1997 |
| K163508 | Velano Vascular | PIVO | 02/09/2017 |
| K190604 | Velano Vascular | PIVO | 05/13/2019 |
| K193569 | Velano Vascular | PIVO(TM) | 01/21/2020 |
| K152924 | VELANO VASCULAR | TIVA┐ | 01/07/2016 |
| K142946 | Velano Vascular, Inc. | TIVA | 01/08/2015 |
| K201237 | VelanoáVascular | VelanoáVascularáBloodáCollectionáAdapterá | 10/03/2022 |
| K230080 | Yangzhou Medline Industry Co., Ltd. | Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood | 07/07/2023 |
| K172763 | Zhejiang Kindly Medical Devices Co.,Ltd | Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with | 06/04/2018 |
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