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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / K253743

510(k) cleared

MiniMed Flex pump

Medtronic Minimed, Inc. · Mar 12, 2026 · K253743

FDA cleared the MiniMed Flex pump from Medtronic Minimed, Inc. on Mar 12, 2026 under K253743, a traditional 510(k). The device falls under product code QFG, Alternate Controller Enabled Insulin Infusion Pump, regulated at 21 CFR 880.5730 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Nov 24, 2025. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Medtronic Minimed, Inc. has 5 other decisions in the tracker over the last 12 months: K261962 (SmartGuard Technology; Predictive Low Glucose Technology), K253701 (SmartGuard Technology; Predictive Low Glucose Technology), K253470 (MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)), K253585 (SmartGuard technology; Predictive Low Glucose technology).

Questions & Answers

What did FDA clear under K253743?

K253743 is the FDA 510(k) for MiniMed Flex pump, submitted by Medtronic Minimed, Inc.. FDA's decision date was Mar 12, 2026, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the MiniMed Flex pump?

Medtronic Minimed, Inc., based in Northridge, CA, is the applicant of record for K253743.

How long did the K253743 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Mar 12, 2026, 108 days later.

← All decisions in March 2026