# K100432: Polyfin Infusion Set, Models MMT-165, MMT-365, MMT-366, MMT-312S and MMT-312L and Sof-Set Infusion Sets

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Jul 9, 2010 after 143 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Sof-set and Polyfin families of infusion sets are indicated for the subcutaneous infusion of medication, including insulin, from a Medtronic MiniMed infusion pump and reservoir.

Source page: https://510kreport.com/device/K100432
Methodology: https://510kreport.com/methodology