# K030137: Medtronic Minimed Sof-Site Infusion Set, Models MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, and MMT-358L9

- Pathway: 510(k) (Traditional)
- Applicant: Avail Medical Products, Inc.
- Decided: Feb 19, 2003 after 36 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) Maersk Medical Quick-set, model Contour: named in the summary without a submission number
- (no number) Medtronic MiniMed Sof-set Ultimate QR infusion sets, models MMT-315 and MMT-316: named in the summary without a submission number

## Indications for use
The Medtronic MiniMed Sof-site infusion sets are indicated for the subcutaneous infusion of medicine, including insulin, from a Medtronic MiniMed infusion pump.

Source page: https://510kreport.com/device/K030137
Methodology: https://510kreport.com/methodology