Cleared Traditional

Dexcom Smart Basal

K252818 · Dexcom, Inc. · Chemistry

Nov 2025

Decision

75d

Days

Class 2

Risk

About This 510(k) Submission

K252818 is an FDA 510(k) clearance for the Dexcom Smart Basal, a Continuous Glucose Monitor Informed Insulin Dose Calculator (Class II — Special Controls, product code QRX), submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on November 18, 2025, 75 days after receiving the submission on September 4, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1358.

Submission Details

510(k) Number	K252818 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 04, 2025
Decision Date	November 18, 2025
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QRX — Continuous Glucose Monitor Informed Insulin Dose Calculator
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1358
Definition	A Continuous Glucose Monitor (cgm)-informed Insulin Dose Calculator Is A Software Device That Calculates Suggested Insulin Doses Based On Cgm Values And/or Other Relevant Information.