# K022317: Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, & Soft-Release-R Infusion Sets

- Pathway: 510(k) (Special)
- Applicant: Sooil Development Co., Ltd.
- Decided: Aug 2, 2002 after 16 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.
1 later device descends 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)
- K001604: Dana Diabecare, Sooil Development Co., Ltd. (2000)

## Most influential descendants
- K063126: Dana Diabecare Iis (2007), 0 descendants of its own

## Indications for use
The DANA DiabecareB I1 external programmable syringe infusion pump and the SUPERLINE-EasyRelease, Soft-Release-ST, and Soft-Release-R Infusion Sets are used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. These devices are not intended for use with blood or blood products.

Source page: https://510kreport.com/device/K022317
Methodology: https://510kreport.com/methodology