# K001829: Minimed Paradigm Insulin Pump, Model 511

- Pathway: 510(k) (Traditional)
- Applicant: Minimed, Inc.
- Decided: Aug 18, 2000 after 63 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
1 of 1 device in its family (counting itself) has 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.

## Recalls of this device
- Aug 7, 2018 · Class I · Z-0178-2020: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.
- Apr 27, 2007 · Not classified · Z-1007-2007: Exposure to Magnetic Resonance Imaging (MRI) has resulted in damage to the component that monitors and controls movement of the motor in the MiniMed Paradigm insulin infusion pump. Although there were
- Aug 29, 2003 · Not classified · Z-0168-04: Water ingresses into the device when in prolonged contact with water causing device to malfunction.

Source page: https://510kreport.com/device/K001829
Methodology: https://510kreport.com/methodology