# K202145: Bigfoot Unity Diabetes Management System

- Pathway: 510(k) (Traditional)
- Applicant: Bigfoot Biomedical, Inc.
- Decided: May 7, 2021 after 280 days
- Product code: QLG (Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems)
- Device class: 2
- Regulation: 21 CFR 862.1355
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170088 (2018). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 4 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193371: FreeStyle Libre 2 Flash Glucose Monitoring System, Abbott Diabetes Care, Inc. (2020) Summary page 4.

## Most influential descendants
- K222280: Bigfoot Unity® Diabetes Management System (2023), 0 descendants of its own

## Recalls of this device
- May 21, 2025 · Class II · Z-1997-2025: Due to a software/firmware issue diabetes management system may provide a device error and cause the insulin pen to become unresponsive and unable to function. This error may pose a potential health r

## Indications for use
The Bigfoot Unity Diabetes Management System is indicated for the management of diabetes in persons age 12 years and older. Bigfoot Unity provides glucose monitoring data via the Abbott FreeStyle Libre 2 Flash Glucose Monitoring sensor. The system incorporates real time alarm capabilities and is designed to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated. The device is intended to provide insulin dose information using the available glucose data to assist persons with diabetes mellitus who use disposable pen-injectors for the self-injection of insulin in implementing health care provider recommended insulin dose regimens. The device is intended for single patient use only and requires a prescription. Bigfoot Unity is also intended to communicate autonomously with digitally connected medical devices where the user manually controls therapy decisions.

Source page: https://510kreport.com/device/K202145
Methodology: https://510kreport.com/methodology