Dexcom Smart Basal
K-Number: K252818 · 2025-11-18
ApplicantDexcom, Inc.
Decision Date2025-11-18
Product CodeQRX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Dexcom Smart Basal is a medical device manufactured by Dexcom, Inc.. It received FDA 510(k) clearance on 2025-11-18 under approval number K252818. The device is classified under product code QRX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Dexcom Smart Basal?
Dexcom Smart Basal is a medical device that received FDA 510(k) clearance on 2025-11-18. It is manufactured by Dexcom, Inc.. The 510(k) number is K252818.
When was Dexcom Smart Basal approved by the FDA?
Dexcom Smart Basal received FDA 510(k) clearance on 2025-11-18, under approval number K252818.
What company makes Dexcom Smart Basal?
Dexcom Smart Basal is manufactured by Dexcom, Inc..
What is the FDA product code for Dexcom Smart Basal?
The FDA product code for Dexcom Smart Basal is QRX.
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K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System
Related Devices (Code: QRX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.