BIGFOOT BIOMEDICAL

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1997-2025Class IIBigfoot Unity Diabetes Management System SW-300689-01 Bigfoot Inject v1 Pen Cap LCAP Firmware 1.3.0 May 21, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K222280Bigfoot Unity® Diabetes Management SystemMarch 1, 2023
K202145Bigfoot Unity Diabetes Management SystemMay 7, 2021