Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JKA — Predicate Candidate Screening
236 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
279 days90th percentile
236clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 | 264 | 0 |
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 | 89 | 0 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® Min | Becton, Dickinson and Company | 2026-04-10 | 254 | 0 |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutain | Becton, Dickinson and Company | 2026-04-10 | 245 | 0 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® | Becton, Dickinson and Company | 2026-03-13 | 256 | 0 |
| K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies | 2025-09-25 | 105 | 0 |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | Becton, Dickinson and Company | 2025-07-03 | 275 | 0 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 | 65 | 0 |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22 | Venocare, Inc. | 2025-05-23 | 143 | 0 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Se | Sol-Millennium Medical, Inc. | 2025-04-30 | 35 | 0 |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | 2025-03-21 | 115 | 0 |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 | 269 | 0 |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024-11-01 | 88 | 0 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024-07-19 | 214 | 0 |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | 2024-03-07 | 178 | 0 |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company | 2024-02-02 | 266 | 0 |
| K231282 | LifeOutcomes C-Quest™ Blood Culture Sampling Device | Lifeoutcomes, LLC | 2024-01-26 | 268 | 0 |
| K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | Becton, Dickinson and Company | 2024-01-19 | 266 | 0 |
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Colle | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2023-12-22 | 95 | 0 |
| K230855 | BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes | Becton, Dickinson and Company | 2023-12-20 | 267 | 0 |
| K232308 | Monarch Blood Collection Set | The Monarch Company | 2023-12-04 | 124 | 0 |
| K230391 | BD MiniDraw™ Capillary Blood Collection System with BD MiniD | Becton, Dickinson and Company | 2023-12-01 | 290 | 0 |
| K213146 | Safety butterfly type blood collection needle, Butterfly typ | Jiangsu Rongye Technology Co., Ltd. | 2023-10-27 | 760 | 0 |
| K220458 | UltraFlo-R Push Button Blood Collection Set | Innovative Medical Technologies, Inc. | 2023-09-29 | 589 | 0 |
| K230865 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2023-09-28 | 183 | 0 |
| K213953 | BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Tr | Becton, Dickinson and Company | 2023-07-17 | 577 | 0 |
| K230080 | Blood Collection Set, Blood Collection Set with Holder, Safe | Yangzhou Medline Industry, Co., Ltd. | 2023-07-07 | 177 | 0 |
| K223854 | Unistik® ShieldLock, Unistik VacuFlip | Owen Mumford, Ltd. | 2023-06-30 | 189 | 0 |
| K230408 | K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) | Sb-Kawasumi Laboratories, Inc. | 2023-06-01 | 106 | 0 |
| K220677 | Kurin Blood Culture Collection Set with Kurin Lock Technolog | Kurin, Inc. | 2023-04-28 | 416 | 0 |
| K223323 | Blood Collection Needle (with/without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2023-03-24 | 144 | 0 |
| K220212 | BD Vacutainer® Push Button Blood Collection Set, BD Vacutain | Becton, Dickinson and Company | 2023-03-24 | 422 | 0 |
| K222478 | BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood | Becton, Dickinson and Company | 2023-03-10 | 206 | 0 |
| K223810 | Kawasumi Multiple Sample Adapter with Pre-Attached Holder (M | Sb-Kawasumi Laboratories, Inc. | 2023-02-24 | 66 | 0 |
| K222299 | Steripath Micro Blood Collection System | Magnolia Medical Technologies | 2022-11-30 | 121 | 0 |
| K213690 | Eclipse Blood Collection Set | Eclipse Medcorp, LLC | 2022-10-26 | 337 | 0 |
| K222141 | Safety Blood Collection Needle (Without Needle Holder) | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-10-21 | 93 | 0 |
| K201237 | Velano Vascular Blood Collection Adapter | Velano Vascular | 2022-10-03 | 879 | 0 |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | 2022-08-30 | 279 | 0 |
| K220799 | K-SHIELD Zen | Sb-Kawasumi Laboratories, Inc. | 2022-08-29 | 164 | 0 |
| K220900 | Safety Blood Collection Needles with/without Needle Holder | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-08-10 | 135 | 0 |
| K220258 | 20G Open-System Ally Device Kit (AV100000), 22G Open-System | Avia Vascular | 2022-07-14 | 164 | 0 |
| K212724 | BD Vacutainer UltraTouch Push Button Blood Collection Set | Becton, Dickinson and Company | 2022-02-04 | 161 | 0 |
| K212019 | Blood Collection Needle for Single Use & Blood Collection Ne | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-11-04 | 129 | 0 |
| K201009 | CHIRAVAC Blood Collection Needles | Chirana T. Injecta | 2021-07-21 | 460 | 0 |
| K202325 | EasyPoint Blood Collection Plus | Retractable Technologies, Inc. | 2021-04-09 | 235 | 0 |
| K202188 | Safety Blood Collection Sets for Single Use | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-02-19 | 199 | 0 |
| K202446 | BD Preset Syringe & BD A-Line Syringe | Becton, Dickinson and Company | 2020-09-25 | 30 | 0 |
| K200027 | Blood Collection Needle with/without Holder, Safety Blood Co | Jiangsu Caina Medical Co.,Ltd | 2020-09-09 | 247 | 0 |
| K193074 | Bevel Up Holder | Nsp Tech Pte, Ltd. | 2020-04-21 | 169 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda