510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193642Substantially Equivalent

Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System

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

K193642 is the FDA 510(k) clearance record for Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, a class II device, cleared for Dexcom, Inc. on under FDA product code QDK (Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management). FDA's definition for product code QDK reads: "An integrated continuous glucose monitoring system for non-intensive diabetes management is intended to replace finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes who do not have significant risk...". FDA records list 28 510(k) clearances for Dexcom, Inc., from to . As of , FDA records show no recalls naming K193642.

Clearance record

Decision date
Received
(30 days to decision)
Product code
QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dexcom, Inc. 6340 Sequence Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDK

Trailing 12 months

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

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