PPS Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS Pi Pressure Injectable Safety Huber
FDA 510(k) K120261 · Perouse Medical
510(k) numberK120261
Submission
- Device name
- PPS Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS Pi Pressure Injectable Safety Huber
- Applicant
- Perouse Medical
France, FR - Received
- January 27, 2012
- Decision date
- May 2, 2012
- 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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| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
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| 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 |
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Questions and answers
When was PPS Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS Pi Pressure Injectable Safety Huber cleared by the FDA?
PPS Pi Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS Pi Pressure Injectable Safety Huber (K120261) received a 510(k) decision of Substantially Equivalent on May 2, 2012, 96 days after the submission was received.
What is the product code of K120261?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.