# Dexcom, Inc.

- Location (FDA's records): San Diego, CA
- FDA decisions: 28 (2006–2026): 25 510(k) clearances, 1 De Novo grant and 2 original PMA approvals
- Product codes: QBJ (15), QDK (4), SAF (2), MDS (2), SBH (2), QRX (1), QDL (1), QII (1)
- 510(k) review time since 2016: median 25 days, against 74 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 31 (30 its own); citations of its devices by later devices: 33 (30 its own)
- Recalls linked to its devices: 18 (6 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Welldoc, Inc.: 1 (https://510kreport.com/company/welldoc)

## Firms that cite its devices most
- Abbott Diabetes Care, Inc.: 1 (https://510kreport.com/company/abbott-diabetes-care)
- Signos, Inc.: 1 (https://510kreport.com/company/signos)
- DreaMed Diabetes, Ltd.: 1 (https://510kreport.com/company/dreamed-diabetes)

## Its most-cited devices
- DEN170088: Dexcom G6 Continuous Glucose Monitoring System (2018), cited by 4
- K234070: Stelo Glucose Biosensor System (2024), cited by 3
- K240902: Dexcom G7 Continuous Glucose Monitoring System (2024), cited by 3
- K191450: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System (2019), cited by 3
- K200876: Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System (2020), cited by 2
- K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System (2025), cited by 2

## Recent decisions
- K262472: Stelo Glucose Biosensor System (Aug 11, 2026)
- K260935: Stelo Glucose Biosensor System (Jun 12, 2026)
- K261402: Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System (Jun 8, 2026)
- K261359: Stelo Glucose Biosensor System (May 21, 2026)
- K253737: Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Feb 3, 2026)
- K253710: Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System (Dec 17, 2025)
- K252818: Dexcom Smart Basal (Nov 18, 2025)
- K243214: Dexcom G7 15 Day Continuous Glucose Monitoring System (Apr 9, 2025)

Source page: https://510kreport.com/company/dexcom