# K041545: Contact Detach

- Pathway: 510(k) (Special)
- Applicant: Unomedical A/S
- Decided: Jun 30, 2004 after 21 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K972135 (1997). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
2 of 5 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)
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set, P/L Biomedical (1997) Summary page 1.
- (no number) unmodified Contact sets: named in the summary without a submission number
- (no number) Comfort Sets: named in the summary without a submission number

## 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

## Recalls of this device
- Nov 7, 2014 · Class II · Z-0356-2017: Tubing detachment
- Nov 7, 2014 · Class II · Z-0360-2017: 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

## Indications for use
The Contact DetachTM is indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Source page: https://510kreport.com/device/K041545
Methodology: https://510kreport.com/methodology