BD Vacutainer UltraTouch Push Button Blood Collection Set
FDA 510(k) K212724 · Becton, Dickinson and Company
510(k) numberK212724
Submission
- Device name
- BD Vacutainer UltraTouch Push Button Blood Collection Set
- Applicant
- Becton, Dickinson and Company
Franklin Lakes, NJ, US - Received
- August 27, 2021
- Decision date
- February 4, 2022
- 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 |
| 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 |
More from Sol-Millennium Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260128 | BD Preset and BD A-Line Arterial Blood Collection SyringesJKA · Special | 04/15/2026SE |
| K252506 | BD Vacutainer® Safety-Lok Blood Collection Set; BD Vacutainer® Safety-Lok Blood…JKA · Traditional | 04/10/2026SE |
| K252378 | BD® MiniDraw Capillary Blood Collection System with BD® MiniDraw SST Capillary Blood…JKA · Traditional | 04/10/2026SE |
| K260184 | Onclarity Self-Collection KitSEP · Traditional | 04/02/2026SE |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST), BD Vacutainer® Sodium Heparin Blood…JKA · Traditional | 03/13/2026SE |
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP SyringeNGT · Traditional | 12/02/2025SE |
| K250358 | BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR…PCI · Traditional | 10/31/2025SE |
| K250059 | BD PhaSeal Optima Connecting Set (C83-O); BD PhaSeal Optima Spike Set (C180-O)ONB · Traditional | 09/12/2025SE |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional | 08/08/2025SE |
| K251350 | BD Plastipak SyringeFMF · Traditional | 07/29/2025SE |
Questions and answers
When was BD Vacutainer UltraTouch Push Button Blood Collection Set cleared by the FDA?
BD Vacutainer UltraTouch Push Button Blood Collection Set (K212724) received a 510(k) decision of Substantially Equivalent on February 4, 2022, 161 days after the submission was received.
What is the product code of K212724?
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.