510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN140038Unknown

Dexcom Share Direct Secondary Displays

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

DEN140038 is the FDA 510(k) clearance record for Dexcom Share Direct Secondary Displays, a class II device, cleared for Dexcom, Inc. on under FDA product code PJT (Continuous Glucose Monitor Secondary Display). FDA's definition for product code PJT reads: "The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for...". FDA records list 28 510(k) clearances for Dexcom, Inc., from to . As of , FDA records show no recalls naming DEN140038.

Clearance record

Decision date
Received
(39 days to decision)
Product code
PJT Continuous Glucose Monitor Secondary Display
Regulation
21 CFR 862.1350
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dexcom, Inc. 6340 Sequence Dr., San Diego CA
Third party review
No

Clearances, product code PJT

Trailing 12 months

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

FDA records show no clearances under product code PJT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJT, 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