# K253743: MiniMed Flex pump

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed, Inc.
- Decided: Mar 12, 2026 after 108 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K010362 (2001). 24 ancestors in all.
No later device cites it as a predicate yet.
3 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251032: MiniMed 780G insulin pump, Medtronic Minimed, Inc. (2025) Summary page 7.

## Recalls of this device
- Aug 20, 2026 · Class II · Z-0088-2027: Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 func

## Indications for use
The MiniMed Flex pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The MiniMed Flex pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The MiniMed Flex pump is indicated for use in persons 7 years of age and older. The MiniMed Flex pump is intended for single patient use and requires a prescription.

Source page: https://510kreport.com/device/K253743
Methodology: https://510kreport.com/methodology