FDA Product Code
FDA Product Code JKA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1675
510(k) Clearances — 237 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262215 | Profoject Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | 2026-09-25 | Traditional | PDF ↗ |
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 | Traditional | PDF ↗ |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 | Special | PDF ↗ |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | 2026-04-10 | Traditional | PDF ↗ |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | 2026-04-10 | Traditional | PDF ↗ |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | 2026-03-13 | Traditional | PDF ↗ |
| K251812 | Steripath® Flow Blood Collection System | Magnolia Medical Technologies | 2025-09-25 | Traditional | PDF ↗ |
| K243207 | BD Vacutainer® Eclipse Blood Collection Needle | Becton, Dickinson and Company | 2025-07-03 | Traditional | PDF ↗ |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 | Traditional | PDF ↗ |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025-05-23 | Traditional | PDF ↗ |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | 2025-04-30 | Special | PDF ↗ |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | 2025-03-21 | Traditional | PDF ↗ |
| K241586 | PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 | Traditional | PDF ↗ |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024-11-01 | Traditional | PDF ↗ |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024-07-19 | Traditional | PDF ↗ |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | 2024-03-07 | Traditional | PDF ↗ |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company | 2024-02-02 | Traditional | PDF ↗ |
| K231282 | LifeOutcomes C-Quest Blood Culture Sampling Device | Lifeoutcomes, LLC | 2024-01-26 | Traditional | PDF ↗ |
| K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | Becton, Dickinson and Company | 2024-01-19 | Traditional | PDF ↗ |
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023-12-22 | Traditional | PDF ↗ |
| K230855 | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | Becton, Dickinson and Company | 2023-12-20 | Traditional | PDF ↗ |
| K232308 | Monarch Blood Collection Set | The Monarch Company | 2023-12-04 | Traditional | PDF ↗ |
| K230391 | BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | 2023-12-01 | Traditional | PDF ↗ |
| K213146 | Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen | Jiangsu Rongye Technology Co., Ltd. | 2023-10-27 | Traditional | PDF ↗ |
| K220458 | UltraFlo-R Push Button Blood Collection Set | Innovative Medical Technologies, Inc. | 2023-09-29 | Traditional | PDF ↗ |
| K230865 | PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-28 | Traditional | PDF ↗ |
| K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes | Becton, Dickinson and Company | 2023-07-17 | Traditional | PDF ↗ |
| K230080 | Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood | Yangzhou Medline Industry, Co., Ltd. | 2023-07-07 | Traditional | PDF ↗ |
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford, Ltd. | 2023-06-30 | Traditional | PDF ↗ |
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | Sb-Kawasumi Laboratories, Inc. | 2023-06-01 | Traditional | PDF ↗ |
| K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technology | Kurin, Inc. | 2023-04-28 | Traditional | PDF ↗ |
| K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | 2023-03-24 | Traditional | PDF ↗ |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-03-24 | Traditional | PDF ↗ |
| K222478 | BD Vacutainer® Luer-Lok Access Device, BD Vacutainer® Blood Transfer Device | Becton, Dickinson and Company | 2023-03-10 | Traditional | PDF ↗ |
| K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Sb-Kawasumi Laboratories, Inc. | 2023-02-24 | Special | PDF ↗ |
| K222299 | Steripath Micro Blood Collection System | Magnolia Medical Technologies | 2022-11-30 | Traditional | PDF ↗ |
| K213690 | Eclipse Blood Collection Set | Eclipse Medcorp, LLC | 2022-10-26 | Traditional | PDF ↗ |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-10-21 | Traditional | PDF ↗ |
| K201237 | Velano Vascular Blood Collection Adapter | Velano Vascular | 2022-10-03 | Traditional | PDF ↗ |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | 2022-08-30 | Traditional | PDF ↗ |
| K220799 | K-SHIELD Zen | Sb-Kawasumi Laboratories, Inc. | 2022-08-29 | Traditional | PDF ↗ |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-08-10 | Traditional | PDF ↗ |
| K220258 | 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) | Avia Vascular | 2022-07-14 | Traditional | PDF ↗ |
| K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2022-02-04 | Traditional | PDF ↗ |
| K212019 | 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 Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-11-04 | Traditional | PDF ↗ |
| K201009 | CHIRAVAC Blood Collection Needles | Chirana T. Injecta | 2021-07-21 | Traditional | PDF ↗ |
| K202325 | EasyPoint Blood Collection Plus | Retractable Technologies, Inc. | 2021-04-09 | Traditional | PDF ↗ |
| K202188 | Safety Blood Collection Sets for Single Use | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-02-19 | Traditional | PDF ↗ |
| K202446 | BD Preset Syringe & BD A-Line Syringe | Becton, Dickinson and Company | 2020-09-25 | Special | PDF ↗ |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | Jiangsu Caina Medical Co.,Ltd | 2020-09-09 | Traditional | PDF ↗ |
| K193074 | Bevel Up Holder | Nsp Tech Pte, Ltd. | 2020-04-21 | Traditional | PDF ↗ |
| K192247 | Steripath Gen2 Blood Collection System | Magnolia Medical Technologies, Inc. | 2020-02-28 | Traditional | PDF ↗ |
| K191832 | 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) | Kurin, Inc. | 2020-02-04 | Traditional | PDF ↗ |
| K193569 | PIVO(TM) | Velano Vascular | 2020-01-21 | Special | PDF ↗ |
| K181754 | Blood Collection Accessory (BUCA) | Nsp Tech Pte, Ltd. | 2019-07-30 | Traditional | PDF ↗ |
| K181743 | Blood Transfer Accessory (BTA) | Nsp Tech Pte, Ltd. | 2019-07-30 | Traditional | PDF ↗ |
| K190485 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) | Kawasumi Laboratories, Inc. | 2019-07-08 | Traditional | PDF ↗ |
| K190604 | PIVO | Velano Vascular | 2019-05-13 | Special | PDF ↗ |
| K182078 | MiniCollect K2E K2EDTA Tubes | Greiner Bio-One Na, Inc. | 2019-01-25 | Traditional | PDF ↗ |
| K181895 | Kurin PIV Blood Collection Set with High Pressure | Kurin, Inc. | 2019-01-18 | Traditional | PDF ↗ |
| K172763 | 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 Holder | Zhejiang Kindly Medical Devices Co., Ltd. | 2018-06-04 | Traditional | PDF ↗ |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder | Sol-Millennium Medical, Inc. | 2017-05-19 | Traditional | PDF ↗ |
| K163508 | PIVO | Velano Vascular | 2017-02-09 | Special | PDF ↗ |
| K162233 | Kurin Blood Culture Collection Set | Pathway, LLC | 2016-12-23 | Traditional | PDF ↗ |
| K160657 | BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube | Becton, Dickinson and Company | 2016-09-23 | Traditional | PDF ↗ |
| K153309 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2016-02-12 | Special | PDF ↗ |
| K152924 | TIVA¿ | Velano Vascular | 2016-01-07 | Traditional | PDF ↗ |
| K142946 | TIVA | Velano Vascular, Inc. | 2015-01-08 | Traditional | PDF ↗ |
| K133303 | PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device | Bio-Analysis, Inc. | 2014-11-19 | Traditional | PDF ↗ |
| K123987 | IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET | Innovative Medical Technologies, Inc. | 2013-08-27 | Traditional | PDF ↗ |
| K122355 | VANISHPOINT BLOOD COLLECTION SET | Retractable Technologies, Inc. | 2013-08-23 | Traditional | PDF ↗ |
| K122687 | BLOOD CULTURE HOLDER | Greiner Bio-One North America, Inc. | 2013-01-10 | Traditional | PDF ↗ |
| K120490 | QUICK SAMPLER HOLDER | Nipro Medical Corporation | 2012-12-27 | Traditional | PDF ↗ |
| K103041 | VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR | Greiner Bio-One North America, Inc. | 2010-11-09 | Special | PDF ↗ |
| K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | Guangzhou Improve Medical Instruments Co., Ltd. | 2010-07-12 | Traditional | PDF ↗ |
| K101502 | BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 | Becton, Dickinson & CO | 2010-06-29 | Traditional | PDF ↗ |
| K093972 | BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 | Becton, Dickinson & CO | 2010-01-21 | Special | PDF ↗ |
| K091292 | BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 | Becton, Dickinson and Company (BD) | 2009-08-25 | Traditional | PDF ↗ |
| K090737 | HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI | Bio-Rad Laboratories, Inc. | 2009-06-03 | Traditional | PDF ↗ |
| K081929 | VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR | Greiner Bio-One North America, Inc. | 2008-12-16 | Special | PDF ↗ |
| K081229 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING | Smiths Medical Asd, Inc. | 2008-07-21 | Traditional | PDF ↗ |
| K072783 | SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH | Smiths Medical Asd, Inc. | 2007-11-30 | Traditional | PDF ↗ |
| K063852 | ACCESSA CHOLESTEROL PANEL | Home Access Health Corp. | 2007-11-09 | Traditional | PDF ↗ |
| K062932 | AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER | Ahlstrom Mount Holly Springs, LLC | 2007-10-19 | Abbreviated | PDF ↗ |
| K063357 | MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES | Greiner Bio-One North America, Inc. | 2007-07-10 | Traditional | PDF ↗ |
| K061979 | MODIFICATION TO MYALLERGY TEST | Immunetech Corporation | 2006-09-22 | Special | PDF ↗ |
| K060364 | VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE | Teco Diagnostics | 2006-06-15 | Traditional | PDF ↗ |
| K051019 | SAFETY NEEDLE | Sarstedt, Inc. | 2005-07-25 | Traditional | PDF ↗ |
| K043143 | SAFEPICO | Radiometer Medical Aps | 2005-04-22 | Traditional | PDF ↗ |
| K040107 | CYTO-CHEX BCT | Streck Laboratories, Inc. | 2004-07-27 | Traditional | PDF ↗ |
| K041358 | VENOJECT LUER ADAPTER | Terumo Europe N.V. | 2004-05-28 | Traditional | PDF ↗ |
| K041071 | BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 | Becton, Dickinson & CO | 2004-05-14 | Special | PDF ↗ |
| K030394 | FLUID SAMPLE RETRIEVAL SYSTEM | Biomed Personal Metabolic and Nutritional Testing | 2003-10-27 | Traditional | PDF ↗ |
| K030815 | AKERS LABORATORIES INC. BLOOD CELL SEPARATOR | Akers Laboratories, Inc. | 2003-09-17 | Traditional | PDF ↗ |
| K030596 | IMMUNICON CELLSAVE PRESERVATIVE TUBE | Immunicon Corp. | 2003-08-08 | Traditional | PDF ↗ |
| K030076 | PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM | Biomed Personal Metabolic and Nutritional Testing | 2003-07-07 | Traditional | PDF ↗ |
| K030573 | BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 | Bd Vacutainer Systems Preanalyical Solutions | 2003-05-08 | Traditional | PDF ↗ |
| K023971 | VACUETTE TRACE ELEMENTS TUBES | Greiner Bio-One Vacuette North America | 2003-01-27 | Traditional | PDF ↗ |
| K023075 | BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE | Bd Vacutainer Systems Preanalyical Solutions | 2002-11-25 | Traditional | PDF ↗ |
| K023331 | BD VACUTAINER SST II PLUS TUBES | Becton, Dickinson & CO | 2002-11-25 | Traditional | PDF ↗ |
Product code JKA · Class II · Clinical Chemistry. Data: openFDA.