Surflo Winged Infusion Set with Needle Protection (Surshield)
FDA 510(k) K133867 · Terumo Europe N.V.
510(k) numberK133867
Submission
- Device name
- Surflo Winged Infusion Set with Needle Protection (Surshield)
- Applicant
- Terumo Europe N.V.
Leuven, BE - Received
- December 20, 2013
- Decision date
- February 5, 2014
- 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
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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 |
|---|---|---|
| K251447 | K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB)FMI · Traditional | 07/08/2025SE |
| K243309 | 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT)FMI · Special | 05/29/2025SE |
| K243581 | K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC)FMI · Traditional | 04/04/2025SE |
| K230951 | Terumo Injection Filter Needle (NF-3013RBKE05M)QYM · Traditional | 10/18/2023SE |
| K212095 | SurGuard3 Safety Hypodermic NeedleFMI · Traditional | 08/22/2022SE |
| K192057 | K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin…FMI · Special | 10/11/2019SE |
| K161606 | Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSHFMF · Traditional | 02/10/2017SE |
| K151398 | K-Pack II Needle - 29G x 5/16 Thin WallFMI · Special | 06/25/2015SE |
| K150263 | K-Pack II Needle-21G x 2FMI · Special | 04/01/2015SE |
| K133894 | Surflo Winged Infusion Set with Filter & Needle Protection (Surshield)FPA · Traditional | 03/18/2014SE |
Questions and answers
When was Surflo Winged Infusion Set with Needle Protection (Surshield) cleared by the FDA?
Surflo Winged Infusion Set with Needle Protection (Surshield) (K133867) received a 510(k) decision of Substantially Equivalent on February 5, 2014, 47 days after the submission was received.
What is the product code of K133867?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.