# K990801: Minimed 508 Insulin Pump

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Jun 8, 1999 after 90 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 4 cite it directly.
2 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MiniMed Model 507C Insulin Pump: named in the summary without a submission number

## Most influential descendants
- K030747: Prodose Aad System (2004), 10 descendants of its own
- K111210: T:Slim (TM) Insulin Delivery System (2011), 9 descendants of its own
- K133593: T:Slim Insulin Delivery System (2014), 8 descendants of its own
- K141758: T:Slim Insulin Delivery System (2014), 7 descendants of its own
- K042991: I-Neb Aad System (2005), 6 descendants of its own

## Recalls of this device
- Jun 27, 2019 · Class II · Z-1581-2020: The action is being initiated due to potential cybersecurity vulnerabilities related to a series of insulin pumps that are designed to communicate using a wireless radio frequency (RF). An unauthorize
- Aug 7, 2018 · Class I · Z-0177-2020: There is a potential security vulnerability related to the use of the remote controller accessories with the insulin pumps.

## Indications for use
The MiniMed insulin pump, model 508, is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

Source page: https://510kreport.com/device/K990801
Methodology: https://510kreport.com/methodology