510(k) K230391
- Device
- BD MiniDraw? Capillary Blood Collection System with BD MiniDraw? SST? Capillary Blood Collection Tube
- Applicant
- Becton, Dickinson and Company
- 510(k) number
- K230391
- Product code
- JKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-01
- Date received
- 2023-02-14
- Regulation
- 862.1675
- Classification name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Katherine Kenner Lemus
- Address
- 1 Becton Dr. Franklin Lakes NJ US 07417 07417
FDA Registration Numbers#
- 3010131137
- 3012421607
- 3006950086
- 3013055489
- 3008717264
- 3004597845
- 8020616
- 3013188547
- 3042871620
- 3033589330
- 3011088743
- 9617475
- 1832216
- 3003974574
- 2024311
- 2245437
- 1917413
- 3018507299
- 3016904853
- 2243072
- 1424263
- 3030626857
- 3013187142
- 3001452053
- 3012116434
- 1915484
- 3010531069
- 3006425876
- 3019004087
- 8021538
- 3010419931
- 3015997711
- 3008733163
- 3005587132
- 3027553380
- 3010621964
- 3015058854
- 3014456066
- 3013248161
- 2648727
- 3001124136
- 9616567
- 3006285950
- 3009889060
- 3020294761
- 3014579161
- 8010026
- 8020040
- 3004140833
- 3008272066
- 1036836
- 3002637618
- 3014680809
- 3013298431
- 3024537844
- 3029901632
- 9681572
- 3016884191
- 3031789039
- 3009732568
- 1054811
- 3003120666
- 2434982
- 3038772401
- 1055927
- 3030733800
- 1220477
- 3044026004
- 1000163068
- 3004416208
- 3005674478
- 3017210488
- 3011287770
- 1933913
- 1125230
- 3017923561
- 3004425647
- 3016661372
- 3013221738
- 3009976527
Source Documents#
Other 510(k) Records For Product Code JKA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 |
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 |
| 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 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton, Dickinson and Company | 2026-04-10 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | 2026-03-13 |
| K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies | 2025-09-25 |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | Becton, Dickinson and Company | 2025-07-03 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025-05-23 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | 2025-04-30 |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | 2025-03-21 |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024-11-01 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024-07-19 |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | 2024-03-07 |