Orbit Infusion Set
FDA 510(k) K130468 · Ypsomed AG
510(k) numberK130468
Submission
- Device name
- Orbit Infusion Set
- Applicant
- Ypsomed AG
Burgdorf, CH - Received
- February 25, 2013
- Decision date
- March 19, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K243901 | SmartPilot YpsoMate NS-A2.25QOG · Traditional | 08/28/2025SE |
| K171984 | Clickfine Pen Needle, Penfine Classic Pen NeedleFMI · Special | 10/11/2017SE |
| K163400 | Orbit InserterKZH · Traditional | 07/26/2017SE |
| K150921 | Orbit Infusion SetFPA · Traditional | 04/12/2016SE |
| K152514 | Clickfine AutoProtect Pen NeedleFMI · Special | 11/18/2015SE |
| K150662 | Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)FMI · Special | 06/09/2015SE |
| K131125 | Clickfine Pen NeedleFMI · Traditional | 07/05/2013SE |
| K131123 | Clickfine Autoprotect Pen NeedleFMI · Traditional | 07/05/2013SE |
| K110312 | Clickfine Autoprotect Pen NeedleFMI · Traditional | 01/26/2012SE |
| K102108 | Clickfine Pen NeedleFMI · Special | 11/23/2010SE |
Questions and answers
When was Orbit Infusion Set cleared by the FDA?
Orbit Infusion Set (K130468) received a 510(k) decision of Substantially Equivalent on March 19, 2013, 22 days after the submission was received.
What is the product code of K130468?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.