QBJ
18 FDA 510(k) clearances · Product code
88 daysmedian time to decision
357 days90th percentile
18clearances measured
FDA profile
- Official device name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1355
- Medical specialty
- Clinical Chemistry
- FDA 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.
- Adverse events (MAUDE)
- 2021: 254,833 · 2022: 232,288 · 2023: 273,564 · 2024: 347,122 · 2025: 379,890 · 2026: 367,877
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Every clearance here is in the API, with alerts when new ones post.