FDA product code QBJ: Integrated Continuous Glucose Monitoring System, Factory Calibrated

QBJ is the FDA product code for integrated continuous glucose monitoring system, factory calibrated. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel. FDA has cleared 17 510(k) submissions under QBJ, 13 in the last five years, from 2 different applicants. The average 510(k) review took 129 days (median 87); 82 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 23 recalls for QBJ devices, 19 initiated in the last five years.

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.

Classification

FieldValue
Device nameIntegrated Continuous Glucose Monitoring System, Factory Calibrated
Device classClass II
Regulation21 CFR 862.1355
Review panelCH — Clinical Chemistry
Medical specialtyClinical Chemistry
Premarket route510(k)

510(k) clearances per year for QBJ

YearClearancesAvg. review days
2019258
20201247
20211422
20222222
2023498
2024384
20252106
2026256

Compare with all 510(k) review times · Search every QBJ clearance

Top QBJ applicants

ApplicantClearancesLatest
Dexcom, Inc.142026-06-08
Abbott Diabetes Care, Inc.32024-04-23

Most recent QBJ clearances

510(k)ApplicantDeviceDecision dateReview days
K261402Dexcom, Inc.Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring System2026-06-0840
K253737Dexcom, Inc.Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2026-02-0371
K253710Dexcom, Inc.Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System2025-12-1723
K243214Dexcom, Inc.Dexcom G7 15 Day Continuous Glucose Monitoring System2025-04-09188
K233537Abbott Diabetes Care, Inc.FreeStyle Libre 3 Continuous Glucose Monitoring System; FreeStyle Libre 2 Flash Glucose Monitoring System2024-04-23172

Recalls for QBJ devices

23 product recalls in 12 recall events; 19 initiated in the last five years and 20 still open. Most recent: 2026-05-27.

YearRecalls
20181
20191
20201
20211
202515
20264

Frequently asked questions

What is FDA product code QBJ?

QBJ is the FDA product code for integrated continuous glucose monitoring system, factory calibrated. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel.

What device class is QBJ?

Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).

How long does a 510(k) take for product code QBJ?

Across 17 cleared submissions the average was 129 days from receipt to decision (median 87).

Which companies have the most QBJ clearances?

Dexcom, Inc. (14); Abbott Diabetes Care, Inc. (3).

Have QBJ devices been recalled?

Yes: 23 product recalls across 12 recall events; the most recent began 2026-05-27.

Next steps

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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