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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 / June 2026 / K261402

510(k) cleared

Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System

Dexcom, Inc. · Jun 8, 2026 · K261402

FDA cleared the Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System from Dexcom, Inc. on Jun 8, 2026 under K261402, a traditional 510(k). The device falls under product code QBJ, Integrated Continuous Glucose Monitoring System, Factory Calibrated, regulated at 21 CFR 862.1355 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Apr 29, 2026. The decision came 40 days later, inside the 90 FDA-day goal for a 510(k).

Dexcom, Inc. has 6 other decisions in the tracker over the last 12 months: K262472 (Stelo Glucose Biosensor System), K260935 (Stelo Glucose Biosensor System), K261359 (Stelo Glucose Biosensor System), K253737 (Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System).

Questions & Answers

What did FDA clear under K261402?

K261402 is the FDA 510(k) for Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System, submitted by Dexcom, Inc.. FDA's decision date was Jun 8, 2026, under product code QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated).

Who makes the Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System?

Dexcom, Inc., based in San Diego, CA, is the applicant of record for K261402.

How long did the K261402 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on Jun 8, 2026, 40 days later.

← All decisions in June 2026