WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / K260935

510(k) cleared

Stelo Glucose Biosensor System

Dexcom, Inc. · Jun 12, 2026 · K260935

FDA cleared the Stelo Glucose Biosensor System from Dexcom, Inc. on Jun 12, 2026 under K260935, a traditional 510(k). The device falls under product code SBH, Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter, regulated at 21 CFR 862.1355 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Mar 20, 2026. The decision came 84 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), K261402 (Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring 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 K260935?

K260935 is the FDA 510(k) for Stelo Glucose Biosensor System, submitted by Dexcom, Inc.. FDA's decision date was Jun 12, 2026, under product code SBH (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter).

Who makes the Stelo Glucose Biosensor System?

Dexcom, Inc., based in San Diego, CA, is the applicant of record for K260935.

How long did the K260935 review take?

FDA received the submission on Mar 20, 2026 and issued its decision on Jun 12, 2026, 84 days later.

← All decisions in June 2026