Cleared Traditional

K234133 - Dexcom G7 Continuous Glucose Monitoring System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence.

K234133 · Dexcom, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2024
Decision
59d
Days
Class 2
Risk

K234133 is an FDA 510(k) clearance for the Dexcom G7 Continuous Glucose Monitoring System. Classified as Integrated Continuous Glucose Monitoring System, Factory Calibrated (product code QBJ), Class II - Special Controls.

Submitted by Dexcom, Inc. (San Diego, US). The FDA issued a Cleared decision on February 26, 2024 after a review of 59 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 862.1355 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dexcom, Inc. devices

Submission Details

510(k) Number K234133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2023
Decision Date February 26, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 114d · This submission: 59d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1355
Definition An Integrated Continuous Glucose Monitoring System (icgm) Is Intended To Automatically Measure Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. Icgm Systems Are Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices, Including Automated Insulin Dosing Systems, And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Medical Devices For The Purpose Of Managing A Disease Or Condition Related To Glycemic Control.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04794478 Completed Interventional Industry-sponsored

Evaluation of the Safety and Effectiveness of the Dexcom Continuous Glucose Monitoring (CGM) System

482
Patients (actual)
12
Sites
Other
Purpose
Open label
Masking
Condition studied Diabetes Mellitus
Study design Single group
Eligibility All sexes · 2 Years+
Sponsor DexCom, Inc. (industry)
Started 2021-02-19 → Primary completion 2021-08-09 → Completed 2021-10-31
Primary outcome
Dexcom Continuous Glucose Monitoring System Performance
Secondary outcome
System Related Adverse Device Effects
Study completed - no results published. This trial concluded in 2021 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - QBJ Integrated Continuous Glucose Monitoring System, Factory Calibrated

All 16
Devices cleared under the same product code (QBJ) and FDA review panel - the closest regulatory comparables to K234133.
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K253737 · Dexcom, Inc. · Feb 2026
Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System
K253710 · Dexcom, Inc. · Dec 2025
Dexcom G7 15 Day Continuous Glucose Monitoring System
K243214 · Dexcom, Inc. · Apr 2025
FreeStyle Libre 3 Continuous Glucose Monitoring System
K233537 · Abbott Diabetes Care, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring System
K240902 · Dexcom, Inc. · Apr 2024
Dexcom G7 Continuous Glucose Monitoring (CGM) System
K231081 · Dexcom, Inc. · May 2023