# K963948: Minimed Insulin Pump, Model 505

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Apr 8, 1997 after 188 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 K901588 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901588: Minimed (R) Model 506 External Insulin Pump, Medtronic Minimed (1990) Summary page 1.

## Indications for use
The 505 insulin pump is intended for continuous delivery of insulin for the management of diabetes mellitus in persons requiring exogenous insulin. It is not intended or indicated for the delivery of blood or blood products

Source page: https://510kreport.com/device/K963948
Methodology: https://510kreport.com/methodology