Class Class II
Bigfoot Unity® Diabetes Management System (K222280)
Description
Bigfoot Unity® Diabetes Management System by Bigfoot Biomedical, Inc., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222280
Clearance Date2023-03-01
Clearance TypeTraditional
Product CodeQLG
Regulation Number862.1355
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222280
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Bigfoot Unity® Diabetes Management System (K222280) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202145 | Bigfoot Unity Diabetes Management System | Bigfoot Biomedical, Inc. | 2021 |
Trace the full predicate network for K222280
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.