510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182405Substantially Equivalent

Dexcom Pro Q Continuous Glucose Monitoring System

Dexcom, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182405 is the FDA 510(k) clearance record for Dexcom Pro Q Continuous Glucose Monitoring System, a class II device, cleared for Dexcom, Inc. on under FDA product code QDL (Integrated Continuous Glucose Monitoring System For Professional Retrospective Use). FDA's definition for product code QDL reads: "An integrated continuous glucose monitoring system for professional retrospective use is a continuous glucose recording device indicated for the retrospective discovery, analysis, and interpretation of glycemic variability in persons age 2...". FDA records list 28 510(k) clearances for Dexcom, Inc., from to . As of , FDA records show no recalls naming K182405.

Clearance record

Decision date
Received
(59 days to decision)
Product code
QDL Integrated Continuous Glucose Monitoring System For Professional Retrospective Use
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dexcom, Inc. 6310 Sequence Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDL

Trailing 12 months

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

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