Atlas FDA

JKA

236 FDA 510(k) clearances · Product code

92 daysmedian time to decision
279 days90th percentile
236clearances measured

FDA profile

Official device name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1675
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 3,610 · 2022: 3,375 · 2023: 4,400 · 2024: 4,610 · 2025: 6,171 · 2026: 3,233
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Female Culture Device; Male Culture Device; Transfer Device; Access Device (K252899)Zhejiang Kindly Medical Device Co., Ltd.2026-06-02
BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (K260128)Becton, Dickinson and Company2026-04-15
BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube (K252378)Becton, Dickinson and Company2026-04-10
BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder (K252506)Becton, Dickinson and Company2026-04-10
BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes (K252040)Becton, Dickinson and Company2026-03-13
Steripath® Flow™ Blood Collection System (K251812)Magnolia Medical Technologies2025-09-25
BD Vacutainer® Eclipse™ Blood Collection Needle (K243207)Becton, Dickinson and Company2025-07-03
Blood collection tube holders (K250961)Promisemed Hangzhou Meditech Co., Ltd.2025-06-04
Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) (K244047)Venocare, Inc.2025-05-23
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (K250907)Sol-Millennium Medical, Inc.2025-04-30
BD Vacutainer® Multiple Sample Luer Adapter (K243649)Becton, Dickinson and Company2025-03-21
PIVO™ Pro Needle-free Blood Collection Device (K241586)Becton Dickinson Infusion Therapy Systems, Inc.2025-02-27
BD Vacutainer® One Use Holder (K242320)Becton, Dickinson and Company2024-11-01
VACUETTE® QUICKSHIELD Complete (Plus) (K233979)Greiner Bio-One North America, Inc.2024-07-19
Safety Sliding Blood Collection Set (K232781)Jiangsu Caina Medical Co.,Ltd2024-03-07
BD Vacutainer® K2 EDTA Blood Collection Tubes (K231373)Becton, Dickinson and Company2024-02-02
LifeOutcomes C-Quest™ Blood Culture Sampling Device (K231282)Lifeoutcomes, LLC2024-01-26
BD Vacutainer® Fluoride Blood Collection Tubes (K231237)Becton, Dickinson and Company2024-01-19
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 (K232881)Jiangsu Kangbao Medical Equipment Co., Ltd.2023-12-22
BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes (K230855)Becton, Dickinson and Company2023-12-20
Monarch Blood Collection Set (K232308)The Monarch Company2023-12-04
BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube (K230391)Becton, Dickinson and Company2023-12-01
Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen (K213146)Jiangsu Rongye Technology Co., Ltd.2023-10-27
UltraFlo-R Push Button Blood Collection Set (K220458)Innovative Medical Technologies, Inc.2023-09-29
PIVO™ Pro Needle-free Blood Collection Device (K230865)Becton Dickinson Infusion Therapy Systems, Inc.2023-09-28
BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes (K213953)Becton, Dickinson and Company2023-07-17
Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood (K230080)Yangzhou Medline Industry, Co., Ltd.2023-07-07
Unistik® ShieldLock, Unistik VacuFlip (K223854)Owen Mumford, Ltd.2023-06-30
K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) (K230408)Sb-Kawasumi Laboratories, Inc.2023-06-01
Kurin Blood Culture Collection Set with Kurin Lock Technology (K220677)Kurin, Inc.2023-04-28
Blood Collection Needle (with/without Needle Holder) (K223323)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2023-03-24
BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder (K220212)Becton, Dickinson and Company2023-03-24
BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device (K222478)Becton, Dickinson and Company2023-03-10
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K223810)Sb-Kawasumi Laboratories, Inc.2023-02-24
Steripath Micro Blood Collection System (K222299)Magnolia Medical Technologies2022-11-30
Eclipse Blood Collection Set (K213690)Eclipse Medcorp, LLC2022-10-26
Safety Blood Collection Needle (Without Needle Holder) (K222141)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-10-21
Velano Vascular Blood Collection Adapter (K201237)Velano Vascular2022-10-03
SOL-GUARD Safety Pull Button Collection Set (K213718)Sol-Millennium Medical, Inc.2022-08-30
K-SHIELD Zen (K220799)Sb-Kawasumi Laboratories, Inc.2022-08-29
Safety Blood Collection Needles with/without Needle Holder (K220900)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2022-08-10
20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) (K220258)Avia Vascular2022-07-14
BD Vacutainer UltraTouch Push Button Blood Collection Set (K212724)Becton, Dickinson and Company2022-02-04
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 (K212019)Jiangsu Micsafe Medical Technology Co., Ltd.2021-11-04
CHIRAVAC Blood Collection Needles (K201009)Chirana T. Injecta2021-07-21
EasyPoint Blood Collection Plus (K202325)Retractable Technologies, Inc.2021-04-09
Safety Blood Collection Sets for Single Use (K202188)Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.2021-02-19
BD Preset Syringe & BD A-Line Syringe (K202446)Becton, Dickinson and Company2020-09-25
Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (K200027)Jiangsu Caina Medical Co.,Ltd2020-09-09
Bevel Up Holder (K193074)Nsp Tech Pte, Ltd.2020-04-21
Steripath Gen2 Blood Collection System (K192247)Magnolia Medical Technologies, Inc.2020-02-28
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) (K191832)Kurin, Inc.2020-02-04
PIVO(TM) (K193569)Velano Vascular2020-01-21
Blood Transfer Accessory (BTA) (K181743)Nsp Tech Pte, Ltd.2019-07-30
Blood Collection Accessory (BUCA) (K181754)Nsp Tech Pte, Ltd.2019-07-30
Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) (K190485)Kawasumi Laboratories, Inc.2019-07-08
PIVO (K190604)Velano Vascular2019-05-13
MiniCollect K2E K2EDTA Tubes (K182078)Greiner Bio-One Na, Inc.2019-01-25
Kurin PIV Blood Collection Set with High Pressure (K181895)Kurin, Inc.2019-01-18
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 (K172763)Zhejiang Kindly Medical Devices Co., Ltd.2018-06-04
Sol-Care Safety Blood Collection Needle with and without Pre-Attached Holder (K163073)Sol-Millennium Medical, Inc.2017-05-19
PIVO (K163508)Velano Vascular2017-02-09
Kurin Blood Culture Collection Set (K162233)Pathway, LLC2016-12-23
BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube (K160657)Becton, Dickinson and Company2016-09-23
BD Vacutainer UltraTouch Push Button Blood Collection Set (K153309)Becton, Dickinson and Company2016-02-12
TIVA¿ (K152924)Velano Vascular2016-01-07
TIVA (K142946)Velano Vascular, Inc.2015-01-08
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device (K133303)Bio-Analysis, Inc.2014-11-19
IMPROVE BLOOD COLLECTION SET AND IMPROSAFE BLOOD COLLECTION SET (K123987)Innovative Medical Technologies, Inc.2013-08-27
VANISHPOINT BLOOD COLLECTION SET (K122355)Retractable Technologies, Inc.2013-08-23
BLOOD CULTURE HOLDER (K122687)Greiner Bio-One North America, Inc.2013-01-10
QUICK SAMPLER HOLDER (K120490)Nipro Medical Corporation2012-12-27
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR (K103041)Greiner Bio-One North America, Inc.2010-11-09
IMPROVACUTER GEL & CLOT ACTIVATOR TUBE (K093910)Guangzhou Improve Medical Instruments Co., Ltd.2010-07-12
BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 (K101502)Becton, Dickinson & CO2010-06-29
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 (K093972)Becton, Dickinson & CO2010-01-21
BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 (K091292)Becton, Dickinson and Company (BD)2009-08-25
HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI (K090737)Bio-Rad Laboratories, Inc.2009-06-03
VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR (K081929)Greiner Bio-One North America, Inc.2008-12-16
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, WITH 21G, 23G, 25G SAF-T WING (K081229)Smiths Medical Asd, Inc.2008-07-21
SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH SAF-HOLDER DEVICE, MODEL 99200, SAF-T CLOSED BLOOD COLLECTION SYSTEM WITH (K072783)Smiths Medical Asd, Inc.2007-11-30
ACCESSA CHOLESTEROL PANEL (K063852)Home Access Health Corp.2007-11-09
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER (K062932)Ahlstrom Mount Holly Springs, LLC2007-10-19
MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES (K063357)Greiner Bio-One North America, Inc.2007-07-10
MODIFICATION TO MYALLERGY TEST (K061979)Immunetech Corporation2006-09-22
VACU LAB PLAIN TUBE, VACU LAB GEL & CLOT ACTIVATOR TUBE, VACU LAB COAGULATION TUBE (K060364)Teco Diagnostics2006-06-15
SAFETY NEEDLE (K051019)Sarstedt, Inc.2005-07-25
SAFEPICO (K043143)Radiometer Medical Aps2005-04-22
CYTO-CHEX BCT (K040107)Streck Laboratories, Inc.2004-07-27
VENOJECT LUER ADAPTER (K041358)Terumo Europe N.V.2004-05-28
BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 (K041071)Becton, Dickinson & CO2004-05-14
FLUID SAMPLE RETRIEVAL SYSTEM (K030394)Biomed Personal Metabolic and Nutritional Testing2003-10-27
AKERS LABORATORIES INC. BLOOD CELL SEPARATOR (K030815)Akers Laboratories, Inc.2003-09-17
IMMUNICON CELLSAVE PRESERVATIVE TUBE (K030596)Immunicon Corp.2003-08-08
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM (K030076)Biomed Personal Metabolic and Nutritional Testing2003-07-07
BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 (K030573)Bd Vacutainer Systems Preanalyical Solutions2003-05-08
VACUETTE TRACE ELEMENTS TUBES (K023971)Greiner Bio-One Vacuette North America2003-01-27
BD VACUTAINER SST II PLUS TUBES (K023331)Becton, Dickinson & CO2002-11-25
BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE (K023075)Bd Vacutainer Systems Preanalyical Solutions2002-11-25
MY ALLERGY TEST (K021698)Immunetech Corporation2002-09-19
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