Female Culture Device; Male Culture Device; Transfer Device; Access Device
FDA 510(k) K252899 · Zhejiang Kindly Medical Device Co., Ltd.
510(k) numberK252899
Submission
- Device name
- Female Culture Device; Male Culture Device; Transfer Device; Access Device
- Applicant
- Zhejiang Kindly Medical Device Co., Ltd.
Wenzhou, CN - Received
- September 11, 2025
- Decision date
- June 2, 2026
- 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
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|---|---|---|---|
| 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 |
| K250961 | Blood collection tube holdersJKA · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 06/04/2025SE |
| 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 |
|---|---|---|
| K233037 | Sterile Hypodermic Needles for Single UseFMI · Traditional | 12/12/2023SE |
Questions and answers
When was Female Culture Device; Male Culture Device; Transfer Device; Access Device cleared by the FDA?
Female Culture Device; Male Culture Device; Transfer Device; Access Device (K252899) received a 510(k) decision of Substantially Equivalent on June 2, 2026, 264 days after the submission was received.
What is the product code of K252899?
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.