Data / Medical devices / United States / Dexcom, Inc.
Dexcom, Inc.: FDA-registered device maker in San Diego, CA, United States, 8 510(k) clearances
Dexcom, Inc. is registered with the FDA (registration 3004753838) in San Diego, CA, United States. It lists 9 device types. The FDA files 8 510(k) clearances under its listings, the newest dated June 12, 2026. 11 recall events name it as the recalling firm (4 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3004753838
- Address
- 6340 Sequence Dr, San Diego, CA, United States, 92121
- Owner or operator
- DEXCOM, INC. (9071756)
- Roles
- Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer
- First device listed
- March 27, 2006
- Registered through
- 2027
- Brand names listed
- Dexcom API, Dexcom Clarity, Dexcom Flex Continuous Glucose Monitoring System, Dexcom Follow, Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System, Dexcom G7 15 Day Continuous Glucose Monitoring System, Dexcom G7 Continuous Glucose Monitoring System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Glucose Monitor Informed Insulin Dose Calculator | QRX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Continuous Glucose Monitor Retrospective Data Analysis Software | PHV | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Continuous Glucose Monitor Secondary Display | PJT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter | SBH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter | SAF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System For Non-Intensive Diabetes Management | QDK | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System For Professional Directed Retrospective Or Real-Time Use | QII | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | 2 | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2026 | K260935 | Stelo Glucose Biosensor System | SBH | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| June 8, 2026 | K261402 | Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| May 21, 2026 | K261359 | Stelo Glucose Biosensor System | SAF | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| November 18, 2025 | K252818 | Dexcom Smart Basal | QRX | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| January 11, 2023 | K223931 | Dexcom G6 Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| July 29, 2022 | K221259 | Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System | QBJ | Substantially Equivalent | Dexcom, Inc. | accessdata.fda.gov |
| January 23, 2015 | DEN140038 | Dexcom Share Direct Secondary Displays | PJT | Unknown | Dexcom, Inc. | accessdata.fda.gov |
| August 19, 2014 | DEN140016 | STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE | PHV | Unknown | Dexcom, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 27, 2026 | 98968 | Class II | Ongoing | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog Number: STP-AT-012 Software Version: N/A Product Description: Dexcom G7 US Retail Senso | Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infectio | accessdata.fda.gov |
| April 14, 2026 | 98639 | Class II | Ongoing | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM iOS App Model/Catalog Number: SW12300 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM iOS App Comp | A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker | accessdata.fda.gov |
| August 28, 2025 | 97607 | Class I | Ongoing | Brand Name: Dexcom G6 Continuous Glucose Monitoring System Product Name: Dexcom G6 and G6 Pro Android US CGM App Model/Catalog Number: SW11678 Software Version: version 1.15.0 Product Description: Dexcom G6 and G6 Pro An | A software defect in version v1.15.0 of the G6 Android app can cause the app to terminate unexpectedly, which may result in the user not receiving estimated glucose values, alarms, alerts or notifications. This could result in the missed detection of a hyperglycemic or hypoglycemic event, protentional resulting in severe hyperglycemia, diabetic ketoacidosis | accessdata.fda.gov |
| July 24, 2025 | 97262 | Class I | Ongoing | Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM Android App Model/Catalog Number: SW12299 Software Version: version 2.8.0 and earlier Product Description: Dexcom G7 CGM Android App | The affected devices are the Dexcom G7 Continuous Glucose Monitoring System (CGM System) using iOS, watchOS and Android App software (versions 2.8.0 or earlier) and Dexcom ONE+ CGM System using iOS and Android App software (versions 1.4.0 or earlier), henceforth referred to as the App. The affected App does not provide an expected "Sensor Failed" alert when | accessdata.fda.gov |
| May 12, 2025 | 96743 | Class I | Ongoing | Dexcom G6 Glucose Receiver, SKUs (Part Number): STK-FM-001 (MT27408-1) & STK-FR-001 (MT27408-1) | Defective foam or an assembly error may cause the receiver speaker to lose contact with the printed circuit board, leading to missed audible alerts for low or high blood glucose values. A missed audible alert for low or high blood glucose values could lead to untreated hypo or hyperglycemia which can cause seizures, vomiting, loss of consciousness, or death. | accessdata.fda.gov |
| May 5, 2025 | 96684 | Class II | Ongoing | Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system | A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are not being updated and that glucose alerts will not trigger, there is potential for the missed detection of a hyperglycemic or hypoglycemic even | accessdata.fda.gov |
| January 27, 2025 | 96091 | Class II | Ongoing | Dexcom G6, Continuous Glucose Monitoring System, REFs: STK-OM-001, STR-OM-001, STR-OR-001 | Under very rare situations, the Dexcom G6 touchscreen receiver may not provide high or low glucose alarms/alerts as designed, which can result in two different conditions. First, if a receiver operating system.net error occurs when an alarm/alert should be triggered, the initial alarm/alert will not be delivered until a subsequent alarm/alert is triggered. A | accessdata.fda.gov |
| February 3, 2020 | 84891 | Class II | Terminated | Dexcom G4 PLATINUM Continuous Glucose Monitoring System The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age 18 a | The company identified potential interference from hydroxyurea. Patient use of the anti-neoplastic drug may falsely elevate glucose readings on the Continuous Glucose Monitoring Systems. | accessdata.fda.gov |
| November 19, 2019 | 84436 | Class II | Terminated | Brand Name: Dexcom G6 CGM App for iOS Software Number: SW11677 Software Version: Version 1.4.0 up to corrected Version 1.4.4 GUDID Registered GTIN: 00386270000804 | It was reported that the user's low alarm feature on the iOS application were not properly alerting users when the user has enabled the Alert Schedule feature more than 30 days after installing the iOS application. | accessdata.fda.gov |
| July 12, 2019 | 84290 | Class II | Terminated | Dexcom Receiver, REF: MT22719, (Black, Pin, Blue), Rx Only, containing software version SW10617 and revision 4.0.1.048 - Product Usage: A non-adjunctive invasive glucose sensor is intended to determine glucose levels, an | It has been reported that use of the mobile receiver with software version SW10617 rev 4.0.1.048 have reported: 1. the receiver becoming stuck on initialization screen when powering on. This will cause patients not to be able to receive glucose values or alerts; 2. Reinitialization of the receiver without user interaction. If this occurs, the receiver will e | accessdata.fda.gov |
| February 23, 2016 | 73412 | Class I | Terminated | Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons | Customers may not receive an intended audible alarm or alert if relying on hearing the alarm or alert. | accessdata.fda.gov |
Compare with other makers
- All makers of Tape And Bandage, Adhesive
- All makers of Integrated Continuous Glucose Monitoring System, Factory Calibrated
- All makers of Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
- All makers of Continuous Glucose Monitor Secondary Display
- All makers of Integrated Continuous Glucose Monitor For Non-Intensive Glucose Management, Over-The-Counter
Updated June 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.