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510(k) DEN140016

STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE by Dexcom, Inc. — Product Code PHV

DEN140016 is an FDA 510(k) premarket notification submitted by Dexcom, Inc. for the device "STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE". The FDA issued a decision of De Novo Granted on August 19, 2014. The device falls under product code PHV (Continuous Glucose Monitor Retrospective Data Analysis Software), a Class I device regulated under 21 CFR 862.2120. Dexcom, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 19, 2014
Date Received
April 22, 2014
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Continuous Glucose Monitor Retrospective Data Analysis Software
Device Class
Class I
Regulation Number
862.2120
Review Panel
CH
Submission Type

Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device.

Other clearances by Dexcom, Inc.

  • K260935 — Stelo Glucose Biosensor System (June 12, 2026)
  • K261402 — Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Gluco (June 8, 2026)
  • K261359 — Stelo Glucose Biosensor System (May 21, 2026)
  • K253737 — Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuou (February 3, 2026)
  • K253710 — Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuou (December 17, 2025)
  • K252818 — Dexcom Smart Basal (November 18, 2025)
  • K243214 — Dexcom G7 15 Day Continuous Glucose Monitoring System (April 9, 2025)
  • K240902 — Dexcom G7 Continuous Glucose Monitoring System (April 23, 2024)
  • K234070 — Stelo Glucose Biosensor System (March 5, 2024)
  • K234133 — Dexcom G7 Continuous Glucose Monitoring System (February 26, 2024)

FDA data resources