510(k) K241586
- Device
- PIVO Pro Needle-free Blood Collection Device
- Applicant
- Becton Dickinson Infusion Therapy Systems, Inc.
- 510(k) number
- K241586
- Product code
- JKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-02-27
- Date received
- 2024-06-03
- 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
- N
Related Records
Applicant Contact
- Contact
- Amy Moore
- Address
- 9450 S. State St. Sandy UT US 84070 84070
FDA Registration Numbers
- 3000247873
- 3002807408
- 2024311
- 1423537
- 3006425876
- 1063851
- 1024879
- 8041145
- 3016844398
- 1933913
- 3008496607
- 3031233007
- 3013696225
- 1832216
- 3014456066
- 3011088743
- 3021169199
- 3028019212
- 3009518015
- 3033536319
- 3006191977
- 3005587132
- 3031789039
- 3010512490
- 9611446
- 3010934635
- 3015276780
- 8020616
- 3002807968
- 3006285950
- 3023228837
- 3003974574
- 3015997711
- 9617604
- 3026940910
- 9617475
- 3013513377
- 1047843
- 2032112
- 2032521
- 9613662
- 3012598266
- 3014662855
- 1319639
- 3012116434
- 3010194621
- 3009976527
- 1054241
- 3022728142
- 1423455
- 3016884191
- 2018685
- 1915484
- 1423507
- 3005910889
- 3043051314
- 3004597845
- 3009963993
- 3020831613
- 3007616112
- 3010531069
- 3000268902
- 9681835
- 3009742443
- 3014162214
- 9610847
- 3013188547
- 9615908
- 1220477
- 8021764
- 3010220595
- 3010370650
- 1921846
- 3010515547
- 3014570560
- 3008307705
- 3008449424
- 3022964615
- 3022147580
Source Documents
Other 510(k) Records For Product Code JKA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company | 2024-02-02 |
| K231282 | LifeOutcomes C-Quest Blood Culture Sampling Device | Lifeoutcomes, LLC | 2024-01-26 |