# K063126: Dana Diabecare Iis

- Pathway: 510(k) (Special)
- Applicant: Sooil Development Co., Ltd.
- Decided: Feb 2, 2007 after 112 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 K001604 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022317: Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, & Soft-Release-R Infusion Sets, Sooil Development Co., Ltd. (2002) Summary page 1.

## Indications for use
The DANA Diabecare® IIS insulin pump is an external digitally controlled syringe pump that is intended for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. It is not intended for use with blood or blood products.

Source page: https://510kreport.com/device/K063126
Methodology: https://510kreport.com/methodology