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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 / K252818

510(k) cleared

Dexcom Smart Basal

Dexcom, Inc. · Nov 18, 2025 · K252818

FDA cleared the Dexcom Smart Basal from Dexcom, Inc. on Nov 18, 2025 under K252818, a traditional 510(k). The device falls under product code QRX, Continuous Glucose Monitor Informed Insulin Dose Calculator, regulated at 21 CFR 862.1358 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Sep 4, 2025. The decision came 75 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 K252818?

K252818 is the FDA 510(k) for Dexcom Smart Basal, submitted by Dexcom, Inc.. FDA's decision date was Nov 18, 2025, under product code QRX (Continuous Glucose Monitor Informed Insulin Dose Calculator).

Who makes the Dexcom Smart Basal?

Dexcom, Inc., based in San Diego, CA, is the applicant of record for K252818.

How long did the K252818 review take?

FDA received the submission on Sep 4, 2025 and issued its decision on Nov 18, 2025, 75 days later.

← All decisions in November 2025