Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
FDA 510(k) K221078 · Sichuan Prius Biotechnology Co., Ltd.
510(k) numberK221078
Submission
- Device name
- Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use
- Applicant
- Sichuan Prius Biotechnology Co., Ltd.
Yibin, CN - Received
- April 12, 2022
- Decision date
- November 21, 2022
- 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
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 |
|---|---|---|
| K221075 | Infusion Sets for Single UseFPA · Traditional | 11/21/2022SE |
| K221069 | Infusion Sets for Single Use with NeedlesFPA · Traditional | 11/21/2022SE |
| K221080 | Sterile Safety Hypodermic Needles for Single UseFMI · Traditional | 10/04/2022SE |
| K221079 | Sterile Hypodermic Syringes for Single UseFMF · Traditional | 10/04/2022SE |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety NeedlesMEG · Traditional | 10/04/2022SE |
| K221068 | Sterile Hypodermic Syringes for Single Use with NeedlesFMF · Traditional | 10/04/2022SE |
| K221066 | Sterile Hypodermic Needles for Single UseFMI · Traditional | 10/04/2022SE |
| K210908 | Surgical MaskFXX · Traditional | 09/26/2021SE |
Questions and answers
When was Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use cleared by the FDA?
Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use (K221078) received a 510(k) decision of Substantially Equivalent on November 21, 2022, 223 days after the submission was received.
What is the product code of K221078?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.