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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2025-11-18 under 510(k) 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. The listed applicant is Dexcom, Inc.. The 510(k) number is K252818.

When did Dexcom Smart Basal receive FDA 510(k) clearance?

Dexcom Smart Basal received FDA 510(k) clearance on 2025-11-18, under 510(k) number K252818.

Who is the listed applicant for Dexcom Smart Basal?

The FDA 510(k) record lists Dexcom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dexcom Smart Basal?

The FDA product code for Dexcom Smart Basal is QRX.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07681375Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 SensorACTIVE_NOT_RECRUITINGNCT07020936AIDANET PediatricsACTIVE_NOT_RECRUITINGNCT06601166CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on InsulinACTIVE_NOT_RECRUITINGNCT07603284Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi ArabiaACTIVE_NOT_RECRUITINGNCT07681024Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)NOT_YET_RECRUITING

Other records listing Dexcom, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262472Stelo Glucose Biosensor SystemK260935Stelo Glucose Biosensor SystemK261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemK261359Stelo Glucose Biosensor SystemK253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemK253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

View all 26 devices →

Related Devices (Code: QRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231824SmartBolus CalculatorInsulet CorporationK222888BlueStar CGM insulin dose calculatorWelldoc, Inc.K222239SmartBolus CalculatorInsulet CorporationK203772Omnipod 5 SmartBolus CalculatorInsulet Corporation

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.

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