# K011071: Paradigm Quick-Set Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Maersk Medical A/S
- Decided: Jun 7, 2001 after 59 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
21 later devices descend from it; 6 cite it directly.
2 of 22 devices in its family (counting itself) have 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
- K032854: Unomedical Monica Infusion Set (2003), 14 descendants of its own
- K173879: MiniMed Mio Advance infusion set (2018), 3 descendants of its own
- K150059: BD FlowSmart Set (2015), 3 descendants of its own
- K153257: BD FlowSmart Set, MiniMed Pro-Set (2015), 2 descendants of its own
- K061374: Intuition Infusion Sets (2006), 2 descendants of its own

## Recalls of this device
- Jun 7, 2013 · Class I · Z-1668-2013: Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other
- Jun 29, 2009 · Not classified · Z-1705-2009: Approximately 2% of the infusion sets in the affected lots may not allow the insulin pump to vent properly. Venting is necessary to equalize the pressure in the syringe compartment with the surroundin

Source page: https://510kreport.com/device/K011071
Methodology: https://510kreport.com/methodology