# K032484: Medtronic Minimed Paradigm Countach Infusion Set, Model MMT 310

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Oct 28, 2003 after 77 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: 1 generation back to K002138 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002138: Paradigm Silhouette, Models MMT-377, 378, 379, 380, Maersk Medical A/S (2000) Summary page 1.

## Indications for use
The Paradigm Countach infusion set is intended for the subcutaneous infusion of medicine, including insulin, from an infusion pump and reservoir. The set is not intended nor indicated for use with blood or blood products.

Source page: https://510kreport.com/device/K032484
Methodology: https://510kreport.com/methodology