Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
FDA 510(k) K250907 · Sol-Millennium Medical, Inc.
510(k) numberK250907
Submission
- Device name
- Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set
- Applicant
- Sol-Millennium Medical, Inc.
Chicago, IL, US - Received
- March 26, 2025
- Decision date
- April 30, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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|---|---|---|---|
| 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 |
| 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 |
|---|---|---|
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle TrayFMF · Traditional | 08/25/2026SE |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeFMF · Traditional | 06/18/2026SE |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead…QNQ · Traditional | 11/20/2024SE |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without NeedleFMF · Traditional | 10/22/2024SE |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer…FMF · Traditional | 09/20/2024SE |
| K220713 | Sol-Guard Auto-disable SyringeFMF · Traditional | 05/04/2023SE |
| K222744 | Sol-M Luer Lock SyringeFMF · Special | 10/11/2022SE |
| K213718 | SOL-GUARD Safety Pull Button Collection SetJKA · Traditional | 08/30/2022SE |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care…FMI · Traditional | 12/03/2018SE |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre-Attached HolderJKA · Traditional | 05/19/2017SE |
Questions and answers
When was Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set cleared by the FDA?
Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set (K250907) received a 510(k) decision of Substantially Equivalent on April 30, 2025, 35 days after the submission was received.
What is the product code of K250907?
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.