# K013767: Simplicity Infusion Reservoir for Use to Infuse Medicine, Including Insulin, From an External Infusion Pump

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Medivations, Inc.
- Decided: Dec 12, 2001 after 29 days
- Product code: FRN (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: 1 generation back to K991936 (2000). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991936: 3.0 ML Reservoir, Model 103/193, Medtronic Minimed (2000) Summary page 1.

## Most influential descendants
- K051045: Simplechoice 3.0 ML Reservoir Pro Reference Number RP-30 (2005), 1 descendant of its own
- K071418: Dana 3CC Syringe Insulin Reservoir (2007), 0 descendants of its own

## Indications for use
The intended use of the Simplicity Infusion reservoir is to provide a means to infuse medicine, including insulin, from an external infusion pump. The reservoir is not intended for use with blood or blood products.

Source page: https://510kreport.com/device/K013767
Methodology: https://510kreport.com/methodology