510(k) · Cleared
ClearedBigfoot Unity® Diabetes Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bigfoot Biomedical, Inc. · QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Cleared on Mar 1, 2023 as substantially equivalent to K202145 (Bigfoot Biomedical, Inc., 2021) after a 215-day review. Its family tree reaches back 3 generations to 2018. 1 of the 4 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 1, 2023
- Review
- 215 days
- Class
- Class II
- Product code
- QLG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN170088 (2018). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backDEN170088 Dexcom G6 Continuous Glucose Monitoring SystemDexcom, Inc. · 2018
- 2 generations backK193371 FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · Recalled (Class I)
- 1 generation backK202145 Bigfoot Unity Diabetes Management SystemBigfoot Biomedical, Inc. · 2021 · Recalled
- This deviceK222280 Bigfoot Unity® Diabetes Management SystemBigfoot Biomedical, Inc. · 2023
Class I recalls in this family
- K193371 FreeStyle Libre 2 Flash Glucose Monitoring System2 generations back · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN170088 | Dexcom G6 Continuous Glucose Monitoring System | Dexcom, Inc. | 2018 | — |
| −2 | K193371 | FreeStyle Libre 2 Flash Glucose Monitoring System | Abbott Diabetes Care, Inc. | 2020 | Class I |
| −1 | K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | 2021 | 1 |
| 0 (this device) | K222280 | Bigfoot Unity® Diabetes Management System | Bigfoot Biomedical, Inc. | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QLG device
- #1 K210943 FreeStyle Libre 2 Flash Glucose Monitoring…score 12.0 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202145 | Bigfoot Unity Diabetes Management SystemSummary page 4…ss: Class II (21 CFR §862.1355, 21CFR § 880.5860) Product Code: QLG, QOG III. Predicate Device: Bigfoot Unity® Diabetes Management System – K202145 IV. Device Description: The Bigfoot Unity Diabetes Management System (‘Bigfoot Unity System’) integrates continuous gluco… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193371FreeStyle Libre 2 Flash Glucose Monitoring SystemAbbott Diabetes Care, Inc. · 2020 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All QLG devicesQLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QLG
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QLG
259in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QLG
4in 2025
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · QLG
20,199in 2025
MAUDE reports naming product code QLG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1,069 |
| 2021 | 4 | 259 | 0 | 22,500 |
| 2022 | 2 | — | 0 | 26,528 |
| 2023 | 2 | — | 1 | 39,321 |
| 2024 | 0 | — | 0 | 35,108 |
| 2025 | 0 | — | 4 (4) | 20,199 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (129 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222280: Bigfoot Unity® Diabetes Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222280
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026