510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN140016Unknown

Studio on the Cloud Data Management Software

Dexcom, Inc., San Diego CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN140016 is the FDA 510(k) clearance record for STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE, a class I device, cleared for Dexcom, Inc. on under FDA product code PHV (Continuous Glucose Monitor Retrospective Data Analysis Software). FDA's definition for product code PHV reads: "Continuous glucose monitor retrospective data analysis software is intended to analyze and correlate retrospective data from a continuous glucose monitoring device". FDA records list 28 510(k) clearances for Dexcom, Inc., from to . As of , FDA records show no recalls naming DEN140016.

Clearance record

Decision date
Received
(119 days to decision)
Product code
PHV Continuous Glucose Monitor Retrospective Data Analysis Software
Regulation
21 CFR 862.2120
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Dexcom, Inc. 6340 Sequence Dr., San Diego CA
Third party review
No

Clearances, product code PHV

Trailing 12 months

FDA records hold no clearances under product code PHV in the trailing twelve months.

FDA records show no clearances under product code PHV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PHV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260