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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 / September 2025 / K250792

510(k) cleared

t:slim X2 insulin pump with interoperable technology

Tandem Diabetes Care, Inc. · Sep 24, 2025 · K250792

FDA cleared the t:slim X2 insulin pump with interoperable technology from Tandem Diabetes Care, Inc. on Sep 24, 2025 under K250792, 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 Mar 14, 2025. The decision came 194 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tandem Diabetes Care, Inc. has 2 other decisions in the tracker over the last 12 months: K260429 (Control-IQ+ technology), K253074 (Tandem Mobi insulin pump with interoperable technology).

Questions & Answers

What did FDA clear under K250792?

K250792 is the FDA 510(k) for t:slim X2 insulin pump with interoperable technology, submitted by Tandem Diabetes Care, Inc.. FDA's decision date was Sep 24, 2025, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the t:slim X2 insulin pump with interoperable technology?

Tandem Diabetes Care, Inc., based in San Diego, CA, is the applicant of record for K250792.

How long did the K250792 review take?

FDA received the submission on Mar 14, 2025 and issued its decision on Sep 24, 2025, 194 days later.

← All decisions in September 2025

Sources