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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 / May 2026 / K261359

510(k) cleared

Stelo Glucose Biosensor System

Dexcom, Inc. · May 21, 2026 · K261359

FDA cleared the Stelo Glucose Biosensor System from Dexcom, Inc. on May 21, 2026 under K261359, a special 510(k). The device falls under product code SAF, Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, 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 Apr 24, 2026. The decision came 27 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), K253737 (Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System).

Questions & Answers

What did FDA clear under K261359?

K261359 is the FDA 510(k) for Stelo Glucose Biosensor System, submitted by Dexcom, Inc.. FDA's decision date was May 21, 2026, under product code SAF (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter).

Who makes the Stelo Glucose Biosensor System?

Dexcom, Inc., based in San Diego, CA, is the applicant of record for K261359.

How long did the K261359 review take?

FDA received the submission on Apr 24, 2026 and issued its decision on May 21, 2026, 27 days later.

← All decisions in May 2026