# K001604: Dana Diabecare

- Pathway: 510(k) (Traditional)
- Applicant: Sooil Development Co., Ltd.
- Decided: Aug 14, 2000 after 82 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
No predicates in its family tree.
4 later devices descend from it; 3 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022317: Dana Diabecare II Insulin Pump & Superline-Easyrelease, Soft-Release-ST, & Soft-Release-R Infusion Sets (2002), 1 descendant of its own
- K071418: Dana 3CC Syringe Insulin Reservoir (2007), 0 descendants of its own
- K063126: Dana Diabecare Iis (2007), 0 descendants of its own
- K013807: Microjet Quark, Model U100 or U40 (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K001604
Methodology: https://510kreport.com/methodology