FDA product code QLG: Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
QLG is the FDA product code for integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel. FDA has cleared 9 510(k) submissions under QLG, 4 in the last five years, from 2 different applicants. The average 510(k) review took 223 days (median 215). FDA has posted 10 recalls for QLG devices, 9 initiated in the last five years.
Definition
An integrated continuous glucose monitoring system for replacement of finger stick blood glucose testing for diabetes treatment decisions in persons with diabetes, unless otherwise indicated. The system automatically measures glucose in bodily fluids continuously or frequently for a specified period of time. The system is also designed to reliably and securely transmit glucose measurement data to digitally connected devices and are intended to be used alone or in conjunction with these digitally connected devices where the user manually controls actions for therapy decisions. The system is not intended to be used with automated insulin dosing (AID) systems.
Classification
| Field | Value |
|---|---|
| Device name | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Device class | Class II |
| Regulation | 21 CFR 862.1355 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
510(k) clearances per year for QLG
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 190 |
| 2021 | 4 | 258 |
| 2022 | 2 | 240 |
| 2023 | 2 | 152 |
Compare with all 510(k) review times · Search every QLG clearance
Top QLG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Diabetes Care, Inc. | 7 | 2023-02-21 |
| Bigfoot Biomedical, Inc. | 2 | 2023-03-01 |
Most recent QLG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222280 | Bigfoot Biomedical, Inc. | Bigfoot Unity® Diabetes Management System | 2023-03-01 | 215 |
| K223537 | Abbott Diabetes Care, Inc. | FreeStyle Libre 2 System, FreeStyle Libre 3 System | 2023-02-21 | 90 |
| K213996 | Abbott Diabetes Care, Inc. | FreeStyle Libre 3 Continuous Glucose Monitoring System | 2022-05-26 | 157 |
| K212132 | Abbott Diabetes Care, Inc. | FreeStyle Libre 3 Continuous Glucose Monitoring System | 2022-05-26 | 322 |
| K210943 | Abbott Diabetes Care, Inc. | FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) | 2021-11-22 | 237 |
Recalls for QLG devices
10 product recalls in 7 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-11-24.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2023 | 3 |
| 2024 | 1 |
| 2025 | 5 |
Frequently asked questions
What is FDA product code QLG?
QLG is the FDA product code for integrated continuous glucose monitoring system, factory calibrated, not for use with automated insulin delivery systems. It is a Class II device, regulated under 21 CFR 862.1355 and reviewed by the Clinical Chemistry panel.
What device class is QLG?
Class II, regulation 21 CFR 862.1355. Typical premarket route: 510(k).
How long does a 510(k) take for product code QLG?
Across 9 cleared submissions the average was 223 days from receipt to decision (median 215).
Which companies have the most QLG clearances?
Abbott Diabetes Care, Inc. (7); Bigfoot Biomedical, Inc. (2).
Have QLG devices been recalled?
Yes: 10 product recalls across 7 recall events; the most recent began 2025-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code QLG
- Run a recall and safety report across every QLG manufacturer
- Watch product code QLG for new clearances and recalls
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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