Infusion Set for Single Use
FDA 510(k) K162601 · Shinva Ande Healthcare Apparatus Co., Ltd.
510(k) numberK162601
Submission
- Device name
- Infusion Set for Single Use
- Applicant
- Shinva Ande Healthcare Apparatus Co., Ltd.
Zibo, CN - Received
- September 19, 2016
- Decision date
- May 31, 2017
- 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 |
|---|---|---|
| K201460 | Closed System Transfer DeviceONB · Traditional | 11/23/2022SE |
| K220057 | Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for…MEG · Traditional | 10/07/2022SE |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle…MEG · Traditional | 03/01/2022SE |
| K202060 | Disposable IV catheterFOZ · Traditional | 07/23/2021SE |
| K193657 | Disposable Enteral Feeding Syringe with Enfit ConnectorPNR · Traditional | 09/12/2020SE |
Questions and answers
When was Infusion Set for Single Use cleared by the FDA?
Infusion Set for Single Use (K162601) received a 510(k) decision of Substantially Equivalent on May 31, 2017, 254 days after the submission was received.
What is the product code of K162601?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.