# K031917: Medtronic Minimed Paradigm Polyfin QR, Model MMT 312L and 312S

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Aug 19, 2003 after 57 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. The FDA summary names its predicate without a number.
- (no number) Polyfin QR with Wings Infusion Set, Model MMT-365 and MMT-366: named in the summary without a submission number

## Indications for use
The Medtronic MiniMed Paradigm Polyfin QR MMT-312L and MMT-312s are intended for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed Paradigm infusion pump. The set is not intended for use with blood.

Source page: https://510kreport.com/device/K031917
Methodology: https://510kreport.com/methodology