# K093364: Solo Micropump Insulin Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Medingo, Ltd.
- Decided: Jan 25, 2010 after 89 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: 2 generations back to K031373 (2003). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090245: Solo Insulin Patch Pump, Medingo, Ltd. (2009) Summary page 2.
- K031373: Ixl Diabetes Management System, Insulet Corp. (2003) Summary page 2.
- K042792: Ixl-II Diabetes Management System, Insulet Corporation (2005) Summary page 2.

## Indications for use
The SoloTM MicroPump Insulin Delivery System 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/K093364
Methodology: https://510kreport.com/methodology