# K090245: Solo Insulin Patch Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medingo, Ltd.
- Decided: Jul 23, 2009 after 171 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- 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 K031373 (2003). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031373: Ixl Diabetes Management System, Insulet Corp. (2003) Summary page 1.
- K042792: Ixl-II Diabetes Management System, Insulet Corporation (2005) Summary page 1.
- K073356: Paradigm Insulin Infusion Pump, Models MMT-512, MMT-712, MMT-515 and MMT-715, Medtronic Minimed (2008) Summary page 2.

## Most influential descendants
- K093364: Solo Micropump Insulin Delivery System (2010), 0 descendants of its own

## Indications for use
The Solo TM Insulin Patch Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K090245
Methodology: https://510kreport.com/methodology