Infusion Sets for Single Use with Needles
FDA 510(k) K221069 · Sichuan Prius Biotechnology Co., Ltd.
510(k) numberK221069
Submission
- Device name
- Infusion Sets for Single Use with Needles
- 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 |
|---|---|---|
| K221078 | Intravenous Needles for Single Use,Safety Intravenous Needles for Single UseFPA · Traditional | 11/21/2022SE |
| K221075 | Infusion Sets for Single UseFPA · 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 Infusion Sets for Single Use with Needles cleared by the FDA?
Infusion Sets for Single Use with Needles (K221069) 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 K221069?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.