MiniMed Flex pump— 510(k) K253743
Substantially EquivalentMedtronic Minimed, Inc.
FDA 510(k) clearance K253743 for MiniMed Flex pump, Substantially Equivalent on 2026-03-12. Applicant: Medtronic Minimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Medtronic Minimed, Inc.
- Product code
- Code QFG
- Device class
- Class 2
- Regulation
- 21 CFR 880.5730
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Northridge, CA, US
Recent devices under product code QFG
view allMore clearances from Medtronic Minimed, Inc.
view all- K253585 — SmartGuard technology; Predictive Low Glucose technology
- K251217 — SmartGuard technology; Predictive Low Glucose technology
- K251032 — MiniMed 780G insulin pump
- K210714 — Extended Reservoir
- K151236 — MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)
Adverse events under product code QFG
product code QFG- Death
- 228
- Injury
- 118,915
- Malfunction
- 1,001,752
- Other
- 7
- Total
- 1,120,902
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.