510(k) K253743 ยท QFG Alternate Controller Enabled Insulin Infusion Pump
MiniMed Flex pump
| Applicant | Medtronic Minimed, Inc., Northridge CA, US |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Nov 24, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2026 | Medtronic MiniMed, Inc. Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The MiniMed Flex pump is an alternate controller enabled (ACE) pump inte Open, Classified |
QFG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.