Blood collection tube holders
FDA 510(k) K250961 · Promisemed Hangzhou Meditech Co., Ltd.
510(k) numberK250961
Submission
- Device name
- Blood collection tube holders
- Applicant
- Promisemed Hangzhou Meditech Co., Ltd.
Hangzhou City, CN - Received
- March 31, 2025
- Decision date
- June 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1675
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access DeviceJKA · Traditional | Zhejiang Kindly Medical Device Co., Ltd. | 06/02/2026SE |
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | Becton, Dickinson and Company | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | Becton, Dickinson and Company | 04/10/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | Becton, Dickinson and Company | 03/13/2026SE |
| K251812 | Steripath® Flow Blood Collection SystemJKA · Traditional | Magnolia Medical Technologies | 09/25/2025SE |
| K243207 | BD Vacutainer® Eclipse Blood Collection NeedleJKA · Traditional | Becton, Dickinson and Company | 07/03/2025SE |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG)JKA · Traditional | Venocare, Inc. | 05/23/2025SE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection SetJKA · Special | Sol-Millennium Medical, Inc. | 04/30/2025SE |
| K243649 | BD Vacutainer® Multiple Sample Luer AdapterJKA · Traditional | Becton, Dickinson and Company | 03/21/2025SE |
More from Becton, Dickinson and Company
| 510(k) | Device | Decision |
|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | 08/25/2026SE |
| K261196 | Promisemed VeriEcto Automatic Biopsy NeedlesKNW · Special | 05/12/2026SE |
| K261045 | Verifine Safety LancetsFMK · Special | 05/01/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | 04/16/2026SE |
| K250192 | Verisafe Safety Retractable Insulin SyringesFMF · Traditional | 12/10/2025SE |
| K251138 | Promisemed Safety Huber NeedlesPTI · Special | 05/13/2025SE |
| K243332 | Promisemed Safety Huber NeedlesPTI · Special | 03/14/2025SE |
| K243806 | Safety Winged Blood Collection SetsFMI · Special | 01/10/2025SE |
| K240675 | Endoscopic Injection NeedlesFBK · Traditional | 10/04/2024SE |
| K242632 | Verifine® Pen NeedlesFMI · Special | 09/26/2024SE |
Questions and answers
When was Blood collection tube holders cleared by the FDA?
Blood collection tube holders (K250961) received a 510(k) decision of Substantially Equivalent on June 4, 2025, 65 days after the submission was received.
What is the product code of K250961?
The FDA product code is JKA – Tubes, Vials, Systems, Serum Separators, Blood Collection, a Class II (moderate risk) device regulated under 21 CFR 862.1675.