DEXCOM, INC.

FDA Device Registration & Listing · SAN DIEGO, CA, US · Registration 3004753838

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004753838
FEI Number
3004753838
Entity Name
DEXCOM, INC.
City/State/Country
SAN DIEGO, CA, US
Establishment Address
6340 Sequence Dr, SAN DIEGO, CA 92121, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
DEXCOM, INC. (Owner Number: 9071756)
Owner / Operator Contact Address
6340 Sequence Drive, --, San Diego, CA 92121, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
DEN140016
PMA Number
N/A

All Registered Proprietary Names

DEXCOM G7 15 DAY CONTINUOUS GLUCOSE MONITORING (CGM) SYSTEM Dexcom ONE Continuous Glucose Monitoring System Dexcom ONE+ Continuous Glucose Monitoring System Dexcom Overpatch Dexcom G6 Continuous Glucose Monitoring System Stelo Glucose Biosensor System Dexcom G6 Pro Continuous Glucose Monitoring System Dexcom G7 Continuous Glucose Monitoring System Dexcom Clarity Dexcom API

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2025-08-18
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-08-18
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2021-09-24
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2006-03-27
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2025-11-25
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter Clinical Chemistry Class 2 862.1355 2024-03-19
QII Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use Clinical Chemistry Class 2 862.1355 2025-11-25
QDK Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management Clinical Chemistry Class 2 862.1355 2025-11-25
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2025-11-25
KGX Tape And Bandage, Adhesive General Hospital Class 1 880.5240 2025-11-25
QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated Clinical Chemistry Class 2 862.1355 2025-11-25
PHV Continuous Glucose Monitor Retrospective Data Analysis Software Clinical Chemistry Class 1 862.2120 2016-12-19

Official Correspondent

Avi Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DEXCOM, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3027503105 Dexcom (Malaysia) Sdn. Bhd. Bandar Cassia Pulau Pinang, MY
3013435121 Dexcom, Inc. Mesa, AZ, US
3037326582 DEXCOM INTERNATIONAL LIMITED Athenry Galway, IE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K843874 Beiersdorf, Inc. LEUKOPOR SURGICAL TAPE 1985-02-21
K915446 Sun Glitz Corp. STRETCH WRAP 1992-05-06
K833120 Acme United Corp. ONE TIME COMPOUND BENZOIN TINCTURE- 1983-12-29
K870091 Avery Intl. IV SECUREMENT DEVICE USING PCCE THERMO. FILM 1987-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004753838. Last updated year: 2026. Please use registration number 3004753838 when referencing this establishment in official correspondence.
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