510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210943Substantially Equivalent

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Abbott Medical, Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210943 is the FDA 510(k) clearance record for FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App), a class II device, cleared for Abbott Diabetes Care, 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 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K210943.

Clearance record

Decision date
Received
(237 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
Abbott Diabetes Care, Inc. 1360 S. Loop Rd., Alameda 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