WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / July 2026 / K261962

510(k) cleared

SmartGuard Technology; Predictive Low Glucose Technology

Medtronic MiniMed · Jul 9, 2026 · K261962

FDA cleared the SmartGuard Technology; Predictive Low Glucose Technology from Medtronic MiniMed on Jul 9, 2026 under K261962, a special 510(k). The device falls under product code QJI, Interoperable Automated Glycemic Controller, regulated at 21 CFR 862.1356 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jun 11, 2026. The decision came 28 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: 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)), K253585 (SmartGuard technology; Predictive Low Glucose technology).

Questions & Answers

What did FDA clear under K261962?

K261962 is the FDA 510(k) for SmartGuard Technology; Predictive Low Glucose Technology, submitted by Medtronic MiniMed. FDA's decision date was Jul 9, 2026, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the SmartGuard Technology; Predictive Low Glucose Technology?

Medtronic MiniMed, based in Northridge, CA, is the applicant of record for K261962.

How long did the K261962 review take?

FDA received the submission on Jun 11, 2026 and issued its decision on Jul 9, 2026, 28 days later.

← All decisions in July 2026