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FDA 510(k)

Stelo Glucose Biosensor System

K-Number: K234070 · 2024-03-05

ApplicantDexcom, Inc.
Decision Date2024-03-05
Product CodeSAF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Stelo Glucose Biosensor System is a medical device manufactured by Dexcom, Inc.. It received FDA 510(k) clearance on 2024-03-05 under approval number K234070. The device is classified under product code SAF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stelo Glucose Biosensor System?

Stelo Glucose Biosensor System is a medical device that received FDA 510(k) clearance on 2024-03-05. It is manufactured by Dexcom, Inc.. The 510(k) number is K234070.

When was Stelo Glucose Biosensor System approved by the FDA?

Stelo Glucose Biosensor System received FDA 510(k) clearance on 2024-03-05, under approval number K234070.

What company makes Stelo Glucose Biosensor System?

Stelo Glucose Biosensor System is manufactured by Dexcom, Inc..

What is the FDA product code for Stelo Glucose Biosensor System?

The FDA product code for Stelo Glucose Biosensor System is SAF.

Related Clinical Trials

NCT07092761 Evaluation of the Accuracy and Safety of A Novel Real-Time Continuous Glucose Monitoring System RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT05754281 The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System ACTIVE_NOT_RECRUITING NCT03262415 PRECISION Study: Evaluating the Accuracy of the LabPatch Continuous Glucose Monitor COMPLETED NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT07612085 A Wearable Biosensor Patch for Non-Invasive Monitoring for Patients Undergoing Abdominal or Chest Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41491965 From stones to system: integrating kidney stones disease into the cardiovascular-kidney-metabolic continuum. Current opinion in nephrology and hypertension (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Dexcom, Inc.

K182405Dexcom Pro Q Continuous Glucose Monitoring System K182041Dexcom G6 Glucose Program Continuous Glucose Monitoring System DEN170088Dexcom G6 Continuous Glucose Monitoring System K192787Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System K191833Dexcom G6 Pro Continuous Glucose Monitoring System K191450Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System

View all 23 devices →

Related Devices (Code: SAF)

K233655Lingo Glucose SystemAbbott K250106Signos Glucose Monitoring SystemSignos, Inc.

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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