510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261359Substantially Equivalent

Stelo Glucose Biosensor System

Dexcom, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261359 is the FDA 510(k) clearance record for Stelo Glucose Biosensor System, a class II device, cleared for Dexcom, Inc. on under FDA product code SAF (Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter). FDA's definition for product code SAF reads: "An integrated continuous glucose monitoring system (iCGM) for non-intensive glucose monitoring is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time to detect euglycemic and...". FDA records list 28 510(k) clearances for Dexcom, Inc., from to . As of , FDA records show no recalls naming K261359.

Clearance record

Decision date
Received
(27 days to decision)
Product code
SAF Integrated Continuous Glucose Monitor For Non-Intensive Glucose Monitoring, Over-The-Counter
Regulation
21 CFR 862.1355
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Dexcom, Inc. 6340 Sequence Dr., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SAF

Trailing 12 months
1 clearance under product code SAF in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SAF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260