Bigfoot Unity Diabetes Management System— 510(k) K202145

Clearance details

Applicant

Bigfoot Biomedical, Inc.

Product code

Code QLG

Device class

Class 2

Regulation

21 CFR 862.1355

Advisory panel

Clinical Chemistry

Date received

2020-07-31

Decision date

2021-05-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Milpitas, CA, US

• K222280 — Bigfoot Unity® Diabetes Management System2023-03-01
• K223537 — FreeStyle Libre 2 System, FreeStyle Libre 3 System2023-02-21
• K212132 — FreeStyle Libre 3 Continuous Glucose Monitoring System2022-05-26
• K213996 — FreeStyle Libre 3 Continuous Glucose Monitoring System2022-05-26
• K210943 — FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)2021-11-22

Death

27

Injury

40,773

Malfunction

107,857

Other

6

Total

148,663

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1997-2025 — 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 Configuration, Rev H The Bigfoot Unity Diabetes Management System that include the Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) integrates continuous monitoring with insulin dose recommendations. The Pen Caps (Rapid-Acting Insulin Pen Cap [RCAP] and Long-Acting Insulin Pen Cap [LCAP]) are part of the Bigfoot Unity Diabetes Management System.Class II·Ongoing·BIGFOOT BIOMEDICAL·20250521

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K202145.