TK Intravascular Administration Set
FDA 510(k) K191640 · Anhui Tiankang Medical Technology Co., Ltd.
510(k) numberK191640
Submission
- Device name
- TK Intravascular Administration Set
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
Tianchang, CN - Received
- June 19, 2019
- Decision date
- August 26, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K222773 | Feeding TubePIF · Traditional | 08/17/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | 08/17/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 08/12/2023SE |
| K222385 | Bifurcated NeedleSCL · Traditional | 12/06/2022SE |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…FMF · Traditional | 07/14/2022SE |
| K212368 | Surgical Face MaskFXX · Traditional | 10/24/2021SE |
| K210464 | Auto Disable SyringeFMF · Traditional | 08/24/2021SE |
| K191639 | TK Insulin Syringe with/without Saftey Retractable DeviceMEG · Traditional | 09/11/2020SE |
| K191644 | TK Safety NeedleFMI · Traditional | 08/06/2020SE |
| K191642 | TK Sterile Piston Syringe without NeedleFMF · Traditional | 01/06/2020SE |
Questions and answers
When was TK Intravascular Administration Set cleared by the FDA?
TK Intravascular Administration Set (K191640) received a 510(k) decision of Substantially Equivalent on August 26, 2020, 434 days after the submission was received.
What is the product code of K191640?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.