K253743

MiniMed Flex pump

510(k) number
K253743
Device name
MiniMed Flex pump
Applicant
Medtronic Minimed, Inc. CA · US
Product code
QFG — Alternate Controller Enabled Insulin Infusion Pump
Decision date
2026-03-12
Date received
2025-11-24
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain

Also available from FDA: K253743.pdf

Official FDA record: K253743
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.