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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 / April 2026 / K260429

510(k) cleared

Control-IQ+ technology

Tandem Diabetes Care, Inc. · Apr 24, 2026 · K260429

FDA cleared the Control-IQ+ technology from Tandem Diabetes Care, Inc. on Apr 24, 2026 under K260429, a traditional 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 Feb 10, 2026. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

Tandem Diabetes Care, Inc. has 2 other decisions in the tracker over the last 12 months: K253074 (Tandem Mobi insulin pump with interoperable technology), K250792 (t:slim X2 insulin pump with interoperable technology).

Questions & Answers

What did FDA clear under K260429?

K260429 is the FDA 510(k) for Control-IQ+ technology, submitted by Tandem Diabetes Care, Inc.. FDA's decision date was Apr 24, 2026, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the Control-IQ+ technology?

Tandem Diabetes Care, Inc., based in San Diego, CA, is the applicant of record for K260429.

How long did the K260429 review take?

FDA received the submission on Feb 10, 2026 and issued its decision on Apr 24, 2026, 73 days later.

← All decisions in April 2026

Sources