510(k) K250961
- Device
- Blood collection tube holders
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
- 510(k) number
- K250961
- Product code
- JKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-06-04
- Date received
- 2025-03-31
- 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
Applicant Contact#
- Contact
- Zearou Yang
- Address
- # 1388 Cangxing St., Cangqian Community,Yuhang District Hangzhou City CN 311121 311121
FDA Registration Numbers#
- 3014570560
- 1423507
- 3013696225
- 3009976527
- 1832216
- 3010419931
- 3033536319
- 3008449424
- 3013188547
- 1036836
- 3023228837
- 1319639
- 3020460367
- 3031233007
- 3007616112
- 3044026004
- 3017509841
- 1055927
- 3006425876
- 3011088743
- 3015485283
- 1921846
- 3011287770
- 2915274
- 3009963993
- 3006285950
- 1424263
- 3008410596
- 3027553380
- 8020040
- 3013517171
- 3010220595
- 1423537
- 3002637618
- 3030419987
- 3044466317
- 3000268902
- 3036773433
- 3029901632
- 3007829657
- 2018685
- 2243072
- 3013055489
- 3021169199
- 3003744503
- 3042871620
- 9680794
- 2032521
- 3019004087
- 3012598266
- 3008496607
- 3016904853
- 3015309643
- 3020831613
- 3030733800
- 1058584
- 3008337059
- 9680448
- 3022147580
- 3003974574
- 3012502601
- 3012187973
- 3016884191
- 3009495876
- 3013187142
- 3009742443
- 3041276591
- 3014579161
- 3030626857
- 3015276780
- 3006950086
- 8010026
- 3033589330
- 3013652330
- 1043214
- 9614033
- 3014162214
- 3017406698
- 2245437
Source Documents#
Other 510(k) Records For Product Code JKA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262215 | Profoject™ Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | 2026-09-25 |
| 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 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton, Dickinson and Company | 2026-04-10 |
| 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 |
| 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 |
| 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 |