# K002138: Paradigm Silhouette, Models MMT-377, 378, 379, 380

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical A/S
- Decided: Aug 29, 2000 after 43 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K160648: MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio® (2016), 1 descendant of its own
- 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
- K032484: Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310 (2003), 0 descendants of its own

## Recalls of this device
- Nov 7, 2014 · Class II · Z-0359-2017: Tubing detachment
- Nov 4, 2014 · Class II · Z-0524-2015: Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify yo

Source page: https://510kreport.com/device/K002138
Methodology: https://510kreport.com/methodology