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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 / November 2025 / K253074

510(k) cleared

Tandem Mobi insulin pump with interoperable technology

Tandem Diabetes Care, Inc. · Nov 6, 2025 · K253074

FDA cleared the Tandem Mobi insulin pump with interoperable technology from Tandem Diabetes Care, Inc. on Nov 6, 2025 under K253074, 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 Sep 23, 2025. The decision came 44 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: K260429 (Control-IQ+ technology), K250792 (t:slim X2 insulin pump with interoperable technology).

Questions & Answers

What did FDA clear under K253074?

K253074 is the FDA 510(k) for Tandem Mobi insulin pump with interoperable technology, submitted by Tandem Diabetes Care, Inc.. FDA's decision date was Nov 6, 2025, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the Tandem Mobi insulin pump with interoperable technology?

Tandem Diabetes Care, Inc., based in San Diego, CA, is the applicant of record for K253074.

How long did the K253074 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Nov 6, 2025, 44 days later.

← All decisions in November 2025

Sources