Bigfoot Unity Diabetes Management System
Bigfoot Unity combines a FreeStyle Libre 2 glucose sensor, reusable caps for rapid-acting and long-acting insulin pens, and a mobile app. The rapid-acting cap displays glucose data and dose…
Bigfoot Unity combines a FreeStyle Libre 2 glucose sensor, reusable caps for rapid-acting and long-acting insulin pens, and a mobile app. The rapid-acting cap displays glucose data and dose information based on the prescribed regimen.
The long-acting cap displays the prescribed long-acting dose. Users select and inject insulin manually with compatible disposable pens; the caps provide information rather than operating an automatic infusion mechanism.
Listed Item
Bigfoot Unity Diabetes Management System for Humalog-Lispro-Lyumjev and Levemir-Tresiba-Degludec Only
Communication and Records
The components communicate through NFC and Bluetooth. Both pen caps track dose timing, while the app provides glucose-related alerts, historical information and entry of the clinician-prescribed regimen. The system is intended for single-patient use in people aged 12 or older.
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Bigfoot Biomedical, Inc., United States |
|---|---|
| FDA product code | QLG |
| Device type | Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1355 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K202145 |
| Record published | 2021-06-29 |
| Record revised | 2025-07-14 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ASM-10048 | In distribution | |
| ASM-10049 | In distribution | |
| FG-300175 | In distribution | |
| FG-300187 | In distribution | |
| FG-300202 | In distribution | |
| FG-300178 | In distribution | |
| FG-300200 | In distribution | |
| ASM-10053 | In distribution | |
| FG-300203 | In distribution | |
| ASM-10060 | In distribution | |
| FG-300205 | In distribution | |
| FG-300206 | In distribution | |
| FG-300173 | In distribution | |
| FG-300188 | In distribution | |
| FG-300177 | In distribution | |
| FG-300197 | In distribution | |
| FG-300204 | In distribution | |
| FG-300172 | In distribution | |
| ASM-10051 | In distribution | |
| FG-300193 | In distribution | |
| FG-300186 | In distribution | |
| FG-300184 | In distribution | |
| FG-300194 | In distribution | |
| ASM-10027 | In distribution | |
| ASM-10043 | In distribution | |
| SW-300842 | In distribution | |
| FG-300171 | In distribution | |
| FG-300176 | In distribution | |
| FG-300174 | In distribution | |
| FG-300196 | In distribution | |
| FG-300198 | In distribution | |
| FG-300185 | In distribution | |
| ASM-10050 | In distribution | |
| ASM-10046 | In distribution | |
| FG-300191 | In distribution | |
| FG-300190 | In distribution | |
| FG-300199 | In distribution | |
| FG-300179 | In distribution | |
| FG-300192 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bigfoot Unity | Bigfoot Biomedical, Inc. | 15 |
| FreeStyle Libre 2 | Abbott Diabetes Care Limited | 4 |
| FreeStyle Libre 3 | Abbott Diabetes Care Limited | 2 |
| FreeStyle Libre 3 App | Abbott Diabetes Care Limited | 2 |
| Libre App | Abbott Diabetes Care Limited | 1 |
| FreeStyle Libre 2 App | Abbott Diabetes Care Limited | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222280 | 2023-03-01 |
| K202145 | 2021-05-07 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Bigfoot Biomedical, Inc. | 510(k) number | 2025-05-21 | Class II | Software design | 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 risk for people living with diabetes as | 57 pen caps |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.