Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
FDA 510(k) K200027 · Jiangsu Caina Medical Co.,Ltd
510(k) numberK200027
Submission
- Device name
- Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter
- Applicant
- Jiangsu Caina Medical Co.,Ltd
Jiangyin, CN - Received
- January 6, 2020
- Decision date
- September 9, 2020
- 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 |
|---|---|---|
| K232781 | Safety Sliding Blood Collection SetJKA · Traditional | 03/07/2024SE |
| K233190 | ENFit AdaptorPIO · Traditional | 01/18/2024SE |
| K230635 | Pen NeedleFMI · Traditional | 06/02/2023SE |
| K220184 | Pump Alignment SyringeFMF · Traditional | 07/21/2022SE |
| K211593 | Enteral Pump SyringePNR · Traditional | 09/30/2021SE |
| K210217 | Needleless ConnectorFPA · Traditional | 05/17/2021SE |
| K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion SetPTI · Traditional | 04/07/2021SE |
| K201356 | Plastic LOR SyringeCAZ · Traditional | 02/12/2021SE |
| K193022 | Retractable Safety Insulin SyringeMEG · Traditional | 07/20/2020SE |
| K193526 | Syringe with safety needle, Safety needleFMF · Traditional | 07/17/2020SE |
Questions and answers
When was Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter cleared by the FDA?
Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter (K200027) received a 510(k) decision of Substantially Equivalent on September 9, 2020, 247 days after the submission was received.
What is the product code of K200027?
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.