# K071418: Dana 3CC Syringe Insulin Reservoir

- Pathway: 510(k) (Traditional)
- Applicant: Sooil Development Co., Ltd.
- Decided: Sep 4, 2007 after 105 days
- Product code: MRZ (Accessories, Pump, Infusion)
- 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: 3 generations back to K991936 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 1.
- K051045: Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30, Spectrx, Inc. (2005) Summary page 1.
- K024056: Sureset 3.0 ML Reservoir, Model 24-103, Applied Diabetes Research, Incorporated (2003) Summary page 1.
- K013767: Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump, Sterling Medivations, Inc. (2001) Summary page 1.
- K991936: 3.0 ML Reservoir, Model 103/193, Medtronic Minimed (2000) Summary page 1.

## Indications for use
The DANA 3cc Syringe Insulin Reservoir is an accessory to the DANA Diabecare® Insulin Pumps. The DANA 3cc Syringe Insulin Reservoir is intended for the delivery of insulin from the DANA Diabecare® Insulin Pumps using specified insulin administration sets. The DANA 3cc Syringe Insulin Reservoir is intended exclusively for use with the DANA Diabecare® Insulin Pumps. The DANA Diabecare® Insulin Pumps are external programmable syringe infusion pumps used for the subcutaneous delivery of insulin for the treatment of diabetes mellitus. The pumps are not intended for use with blood or blood products.

Source page: https://510kreport.com/device/K071418
Methodology: https://510kreport.com/methodology