510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K202145Substantially Equivalent

Bigfoot Unity Diabetes Management System

Bigfoot Biomedical, Inc., Milpitas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K202145 is the FDA 510(k) clearance record for Bigfoot Unity Diabetes Management System, a class II device, cleared for Bigfoot Biomedical, Inc. on under FDA product code QLG (Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems). FDA's definition for product code QLG reads: "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...". FDA records list 2 510(k) clearances for Bigfoot Biomedical, Inc., from to . As of , FDA records show one recall naming K202145.

Clearance record

Decision date
Received
(280 days to decision)
Product code
QLG Integrated Continuous Glucose Monitoring System, Factory Calibrated, Not For Use With Automated Insulin Delivery Systems
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bigfoot Biomedical, Inc. 1820 Mccarthy Blvd., Milpitas CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QLG

Trailing 12 months

FDA records hold no clearances under product code QLG in the trailing twelve months.

FDA records show no clearances under product code QLG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QLG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260