# K030149: Medtronic Minimed Sof-Site Infusion Set, Models MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, and MMT-359L9

- Pathway: 510(k) (Traditional)
- Applicant: Avail Medical Products, Inc.
- Decided: Mar 20, 2003 after 64 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) Medtronic MiniMed Paradigm Quick-set, models MMT-396, MMT-397, MMT-398, and MMT-399: named in the summary without a submission number
- (no number) Medtronic MiniMed Paradigm Sof-set Ultimate QR infusion sets, models MMT-317 and MMT-318: named in the summary without a submission number

## Most influential descendants
- K052389: I-PORT (2005), 1 descendant of its own
- K120337: I-Port Advance Injection Port (2012), 0 descendants of its own

## Recalls of this device
- Mar 2, 2004 · Not classified · Z-0910-04: Possibility of interrupted insulin flow. This posting is for a recall that occurred in March 2004, also posted on the FDA website in 2004.

## Indications for use
The Medtronic MiniMed Paradigm 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/K030149
Methodology: https://510kreport.com/methodology