# K013807: Microjet Quark, Model U100 or U40

- Pathway: 510(k) (Traditional)
- Applicant: Cane S.R.L.
- Decided: Dec 12, 2001 after 27 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 K001604 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001604: Dana Diabecare, Sooil Development Co., Ltd. (2000) Summary page 2.

## Indications for use
The Microjet Quark U-100 ambulatory infusion pump has been designed only for use in subcutaneous infusion of insulin for the treatment of diabetes mellitus.

Source page: https://510kreport.com/device/K013807
Methodology: https://510kreport.com/methodology