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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 / January 2026 / K253512

510(k) cleared

MiniMed Go App

Medtronic Minimed · Jan 8, 2026 · K253512

FDA cleared the MiniMed Go App from Medtronic Minimed on Jan 8, 2026 under K253512, a traditional 510(k). The device falls under product code NDC, Calculator, Drug Dose, regulated at 21 CFR 868.1890 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Nov 6, 2025. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

Medtronic Minimed has 5 other decisions in the tracker over the last 12 months: K261962 (SmartGuard Technology; Predictive Low Glucose Technology), K253743 (MiniMed Flex pump), K253701 (SmartGuard Technology; Predictive Low Glucose Technology), K253470 (MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)).

Questions & Answers

What did FDA clear under K253512?

K253512 is the FDA 510(k) for MiniMed Go App, submitted by Medtronic Minimed. FDA's decision date was Jan 8, 2026, under product code NDC (Calculator, Drug Dose).

Who makes the MiniMed Go App?

Medtronic Minimed, based in Los Angeles, CA, is the applicant of record for K253512.

How long did the K253512 review take?

FDA received the submission on Nov 6, 2025 and issued its decision on Jan 8, 2026, 63 days later.

← All decisions in January 2026