Cleared Traditional

Bigfoot Unity? Diabetes Management System

K222280 · Bigfoot Biomedical, Inc. · Chemistry

Mar 2023

Decision

215d

Days

Class 2

Risk

About This 510(k) Submission

K222280 is an FDA 510(k) clearance for the Bigfoot Unity? Diabetes Management System, a Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (Class II — Special Controls, product code QLG), submitted by Bigfoot Biomedical, Inc. (Milpitas, US). The FDA issued a Cleared decision on March 1, 2023, 215 days after receiving the submission on July 29, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1355.

Submission Details

510(k) Number	K222280 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2022
Decision Date	March 01, 2023
Days to Decision	215 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF

Device Classification

Product Code	QLG — Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1355
Definition	An Integrated Continuous Glucose Monitoring System For Replacement Of Finger Stick Blood Glucose Testing For Diabetes Treatment Decisions In Persons With Diabetes, Unless Otherwise Indicated. The System Automatically Measures Glucose In Bodily Fluids Continuously Or Frequently For A Specified Period Of Time. The System Is Also Designed To Reliably And Securely Transmit Glucose Measurement Data To Digitally Connected Devices And Are Intended To Be Used Alone Or In Conjunction With These Digitally Connected Devices Where The User Manually Controls Actions For Therapy Decisions. The System Is Not Intended To Be Used With Automated Insulin Dosing (aid) Systems.