510(k) K202145 ยท QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Bigfoot Unity Diabetes Management System
| Applicant | Bigfoot Biomedical, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, May 7, 2021 |
| Received | Jul 31, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 20, 2025 | BIGFOOT BIOMEDICAL Bigfoot Unity Diabetes Management System
SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 Release Configuration, Rev H
SW-300689-02 Bigfoot Inject v1 Pen Cap RCAP Firmware 1.3.0 Release Conf Open, Classified |
QLG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.