JKA · Tubes, Vials, Systems, Serum Separators, Blood Collection
Clinical Chemistry · 21 CFR 862.1675 · Class 2
Overview
| Product Code | JKA |
|---|---|
| Device Name | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Regulation | 21 CFR 862.1675 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 236)
Showing 20 most recent of 236 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260128 | BD Preset and BD A-Line Arterial Blood Collection Syringes | Becton, Dickinson and Company | Apr 15, 2026 | SESE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | Apr 10, 2026 | SESE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood Collection Tube | Becton, Dickinson and Company | Apr 10, 2026 | SESE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | Mar 13, 2026 | SESE |
| K251812 | Steripath® Flow Blood Collection System | Magnolia Medical Technologies | Sep 25, 2025 | SESE |
| K243207 | BD Vacutainer® Eclipse Blood Collection Needle | Becton, Dickinson and Company | Jul 3, 2025 | SESE |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | Jun 4, 2025 | SESE |
| K244047 | Navi Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | May 23, 2025 | SESE |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | Apr 30, 2025 | SESE |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | Mar 21, 2025 | SESE |
| K241586 | PIVO Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | Feb 27, 2025 | SESE |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | Nov 1, 2024 | SESE |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | Jul 19, 2024 | SESE |
| K232781 | Safety Sliding Blood Collection Set | Jiangsu Caina Medical Co.,Ltd | Mar 7, 2024 | SESE |
| K231373 | BD Vacutainer® K2 EDTA Blood Collection Tubes | Becton, Dickinson and Company | Feb 2, 2024 | SESE |
| K231282 | LifeOutcomes C-Quest Blood Culture Sampling Device | Lifeoutcomes, LLC | Jan 26, 2024 | SESE |
| K231237 | BD Vacutainer® Fluoride Blood Collection Tubes | Becton, Dickinson and Company | Jan 19, 2024 | SESE |
| K232881 | Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder | Jiangsu Kangbao Medical Equipment Co., Ltd. | Dec 22, 2023 | SESE |
| K230855 | BD Vacutainer® Serum Separator (SST) Blood Collection Tubes | Becton, Dickinson and Company | Dec 20, 2023 | SESE |
| K232308 | Monarch Blood Collection Set | The Monarch Company | Dec 4, 2023 | SESE |
Top Applicants
- Becton, Dickinson and Company — 18 clearances
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 13 clearances
- Becton Dickinson Vacutainer Systems — 11 clearances
- Sherwood Medical Co. — 9 clearances
- Becton, Dickinson & CO — 8 clearances
