Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps
FDA 510(k) K120872 · Unomedical A/S Infusion Devices
510(k) numberK120872
Submission
- Device name
- Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps
- Applicant
- Unomedical A/S Infusion Devices
Osted, DK - Received
- March 22, 2012
- Decision date
- April 20, 2012
- 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
| 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 |
Questions and answers
When was Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps cleared by the FDA?
Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl Infusion Pumps (K120872) received a 510(k) decision of Substantially Equivalent on April 20, 2012, 29 days after the submission was received.
What is the product code of K120872?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.