Bigfoot Unity® Diabetes Management System— 510(k) K222280

Substantially Equivalent

Bigfoot Biomedical, Inc.

FDA 510(k) clearance K222280 for Bigfoot Unity® Diabetes Management System, Substantially Equivalent on 2023-03-01. Applicant: Bigfoot Biomedical, Inc..

Clearance details

Applicant: Bigfoot Biomedical, Inc.
Product code: Code QLG
Advisory panel: Clinical Chemistry
Date received: 2022-07-29
Decision date: 2023-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milpitas, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QLG

product code QLG

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.