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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 / December 2025 / K253710

510(k) cleared

Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

Dexcom, Inc. · Dec 17, 2025 · K253710

FDA cleared the Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System from Dexcom, Inc. on Dec 17, 2025 under K253710, a special 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 Nov 24, 2025. The decision came 23 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), K261402 (Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System), K261359 (Stelo Glucose Biosensor System).

Questions & Answers

What did FDA clear under K253710?

K253710 is the FDA 510(k) for Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System, submitted by Dexcom, Inc.. FDA's decision date was Dec 17, 2025, under product code QBJ (Integrated Continuous Glucose Monitoring System, Factory Calibrated).

Who makes the Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System?

Dexcom, Inc., based in San Diego, CA, is the applicant of record for K253710.

How long did the K253710 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Dec 17, 2025, 23 days later.

← All decisions in December 2025