# K160648: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical A/S
- Decided: Aug 10, 2016 after 156 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K972135 (1997). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011071: Paradigm Quick-Set Infusion Set, Maersk Medical A/S (2001) Summary page 4.
- K041545: Contact Detach, Unomedical A/S (2004) Summary page 4.
- K002138: Paradigm Silhouette, Models MMT-377, 378, 379, 380, Maersk Medical A/S (2000) Summary page 4.
- K032854: Unomedical Monica Infusion Set, Unomedical A/S (2003) Summary page 4.

## Most influential descendants
- K162812: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set (2017), 0 descendants of its own

## Recalls of this device
- Sep 10, 2017 · Class II · Z-0109-2018: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
- Sep 10, 2017 · Class II · Z-0110-2018: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
- Sep 10, 2017 · Class II · Z-0107-2018: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
- Sep 10, 2017 · Class II · Z-0108-2018: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

## Indications for use
These sets are intended to be used with Medtronic Paradigm Insulin Subcutaneous Infusion Pumps for continuous subcutaneous insulin infusion by patients or caregivers in the home environment.

Source page: https://510kreport.com/device/K160648
Methodology: https://510kreport.com/methodology