Cleared Traditional

K252818 - Dexcom Smart Basal (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252818 · Dexcom, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2025
Decision
75d
Days
Class 2
Risk

K252818 is an FDA 510(k) clearance for the Dexcom Smart Basal. Classified as Continuous Glucose Monitor Informed Insulin Dose Calculator (product code QRX), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on November 18, 2025 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1358 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexcom, Inc. devices

Submission Details

510(k) Number K252818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 88d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRX Continuous Glucose Monitor Informed Insulin Dose Calculator
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.