# K210544: Medtronic Extended infusion set

- Pathway: 510(k) (Traditional)
- Applicant: Unomedical A/S
- Decided: Jul 16, 2021 after 142 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K972135 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173879: MiniMed Mio Advance infusion set, Unomedical A/S (2018) Summary page 4.

## Indications for use
The Medtronic Extended infusion set is indicated for subcutaneous infusion of medication administered by an external pump. The infusion set is indicated for single use.

Source page: https://510kreport.com/device/K210544
Methodology: https://510kreport.com/methodology