MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
FDA 510(k) K160648 · Unomedical A/S
510(k) numberK160648
Submission
- Device name
- MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®
- Applicant
- Unomedical A/S
Osted, DK - Received
- March 7, 2016
- Decision date
- August 10, 2016
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K210544 | Medtronic Extended infusion setFPA · Traditional | 07/16/2021SE |
| K192647 | neria guard Infusion SetFPA · Traditional | 12/13/2019SE |
| K173879 | MiniMed Mio Advance infusion setFPA · Traditional | 03/05/2018SE |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…FPA · Traditional | 11/01/2017SE |
| K132142 | Neria Soft 90 Infusion SetFPA · Traditional | 10/08/2013SE |
| K120337 | I-Port Advance Injection PortFOZ · Abbreviated | 02/16/2012SE |
| K070430 | Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion SetsFPA · Traditional | 04/04/2007SE |
| K061374 | Intuition Infusion SetsFPA · Traditional | 07/31/2006SE |
| K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsFPA · Traditional | 09/01/2005SE |
| K041545 | Contact DetachFPA · Special | 06/30/2004SE |
Questions and answers
When was MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® cleared by the FDA?
MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (K160648) received a 510(k) decision of Substantially Equivalent on August 10, 2016, 156 days after the submission was received.
What is the product code of K160648?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.