Cleared Traditional

K202145 - Bigfoot Unity Diabetes Management System (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202145 · Bigfoot Biomedical, Inc. · Chemistry device
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May 2021
Decision
280d
Days
Class 2
Risk

K202145 is an FDA 510(k) clearance for the Bigfoot Unity Diabetes Management System. Classified as Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems (product code QLG), Class II - Special Controls.

Submitted by Bigfoot Biomedical, Inc. (Milpitas, US). The FDA issued a Cleared decision on May 7, 2021 after a review of 280 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1355 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Bigfoot Biomedical, Inc. devices

Submission Details

510(k) Number K202145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2020
Decision Date May 07, 2021
Days to Decision 280 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
192d slower than avg
Panel avg: 88d · This submission: 280d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems

All 8
Devices cleared under the same product code (QLG) and FDA review panel - the closest regulatory comparables to K202145.
Bigfoot Unity® Diabetes Management System
K222280 · Bigfoot Biomedical, Inc. · Mar 2023
FreeStyle Libre 2 System, FreeStyle Libre 3 System
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FreeStyle Libre 3 Continuous Glucose Monitoring System
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FreeStyle Libre 3 Continuous Glucose Monitoring System
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FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)
K210943 · Abbott Diabetes Care, Inc. · Nov 2021
FreeStyle Libre 2 Flash Glucose Monitoring System
K211102 · Abbott Diabetes Care, Inc. · Aug 2021