510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K062347Substantially Equivalent

Ascensia Breeze 2 Blood Glucose Monitoring System

Medrad, Inc., Mishawaka IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K062347 is the FDA 510(k) clearance record for ASCENSIA BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM, a class II device, cleared for Bayer Healthcare, LLC on under FDA product code NBW (System, Test, Blood Glucose, Over The Counter). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K062347.

Clearance record

Decision date
Received
(104 days to decision)
Product code
NBW System, Test, Blood Glucose, Over The Counter
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bayer Healthcare, LLC 430 S. Beiger St., Mishawaka IN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBW

Trailing 12 months
5 clearances under product code NBW in the twelve months to November 2026, October 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NBW, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20260
October 20263
November 20260