JKA — Tubes, Vials, Systems, Serum Separators, Blood Collection Class II
FDA product code JKA covers "Tubes, Vials, Systems, Serum Separators, Blood Collection", a Class II medical device regulated under 21 CFR 862.1675. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JKA
- Device Class
- Class II
- Regulation Number
- 862.1675
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252899 | Zhejiang Kindly Medical Device Co | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Jun 2, 2026 |
| K260128 | Becton, Dickinson And | BD Preset and BD A-Line Arterial Blood Collection Syringes | Apr 15, 2026 |
| K252378 | Becton, Dickinson And | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillar | Apr 10, 2026 |
| K252506 | Becton, Dickinson And | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Bloo | Apr 10, 2026 |
| K252040 | Becton, Dickinson And | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Bloo | Mar 13, 2026 |
| K251812 | Magnolia Medical Technologies | Steripath® Flow Blood Collection System | Sep 25, 2025 |
| K243207 | Becton, Dickinson And | BD Vacutainer® Eclipse Blood Collection Needle | Jul 3, 2025 |
| K250961 | Promisemed Hangzhou Meditech Co | Blood collection tube holders | Jun 4, 2025 |
| K244047 | Venocare | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | May 23, 2025 |
| K250907 | Sol-Millennium Medical | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Apr 30, 2025 |
| K243649 | Becton, Dickinson And | BD Vacutainer® Multiple Sample Luer Adapter | Mar 21, 2025 |
| K241586 | Becton Dickinson Infusion Therapy Systems | PIVO Pro Needle-free Blood Collection Device | Feb 27, 2025 |
| K242320 | Becton, Dickinson And | BD Vacutainer® One Use Holder | Nov 1, 2024 |
| K233979 | Greiner Bio-One North America | VACUETTE® QUICKSHIELD Complete (Plus) | Jul 19, 2024 |
| K232781 | Jiangsu Caina Medical Co | Safety Sliding Blood Collection Set | Mar 7, 2024 |
| K231373 | Becton, Dickinson And | BD Vacutainer® K2 EDTA Blood Collection Tubes | Feb 2, 2024 |
| K231282 | Lifeoutcomes | LifeOutcomes C-Quest Blood Culture Sampling Device | Jan 26, 2024 |
| K231237 | Becton, Dickinson And | BD Vacutainer® Fluoride Blood Collection Tubes | Jan 19, 2024 |
| K232881 | Jiangsu Kangbao Medical Equipment Co | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Col | Dec 22, 2023 |
| K230855 | Becton, Dickinson And | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | Dec 20, 2023 |