U & U Intravascular Administration Set
FDA 510(k) K151151 · U&U Medical Technology Co, Ltd.
510(k) numberK151151
Submission
- Device name
- U & U Intravascular Administration Set
- Applicant
- U&U Medical Technology Co, Ltd.
Changzhou, CN - Received
- April 30, 2015
- Decision date
- September 24, 2015
- 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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| 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 U & U Intravascular Administration Set cleared by the FDA?
U & U Intravascular Administration Set (K151151) received a 510(k) decision of Substantially Equivalent on September 24, 2015, 147 days after the submission was received.
What is the product code of K151151?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.