510(k) K222280
K222280 is an FDA 510(k) premarket notification submitted by Bigfoot Biomedical, Inc. for the device "Bigfoot Unity® Diabetes Management System". The FDA issued a decision of Substantially Equivalent on March 1, 2023. The device falls under product code QLG (Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems), a Class II device regulated under 21 CFR 862.1355. Bigfoot Biomedical, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 2023
- Date Received
- July 29, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
- Device Class
- Class II
- Regulation Number
- 862.1355
- Review Panel
- CH
- Submission Type
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.