DeviceClearance

MiniMed Flex pump— 510(k) K253743

Substantially Equivalent

Medtronic Minimed, Inc.

FDA 510(k) clearance K253743 for MiniMed Flex pump, Substantially Equivalent on 2026-03-12. Applicant: Medtronic Minimed, Inc.. Device class: 2.

Summary

Medtronic Minimed's MiniMed Flex pump is filed under QFG, alternate controller enabled insulin infusion pumps. The record doesn't describe the pump beyond its name and that code name.

Class II, 21 CFR 880.5730. It was a Traditional 510(k), and Clinical Chemistry is both the classification panel and the review panel.

Medtronic Minimed filed from Northridge, California. The decision came 108 calendar days after FDA received it (November 24, 2025 to March 12, 2026).

Clearance details

Applicant
Medtronic Minimed, Inc.
Product code
Product 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
Download summary PDFView on FDA.gov ↗

Recent devices under product code QFG

view all

More clearances from Medtronic Minimed, Inc.

view all

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 →

Recalls naming K253743

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K253743.

Data sourced from openFDA. This site is unofficial and independent of the FDA.