# K052431: Medtronic Minimed Leapfrog II Infusion Set, Models MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Nov 29, 2005 after 84 days
- Product code: FPK (Tubing, Fluid Delivery)
- 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) Unomedical A/S (formerly Maersk Medical), model Contour Infusion Set (Quick-set®): named in the summary without a submission number
- (no number) Avail Medical Products Inc., Sof-Site Infusion Set, models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9: named in the summary without a submission number

## Indications for use
The Medtronic MiniMed Leapfrog II Infusion Set is indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

Source page: https://510kreport.com/device/K052431
Methodology: https://510kreport.com/methodology