510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K241335Substantially Equivalent

Eversense 365 Continuous Glucose Monitoring (CGM) System

Senseonics, Incorporated, Germantown MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K241335 is the FDA 510(k) clearance record for Eversense 365 Continuous Glucose Monitoring (CGM) System, a class II device, cleared for Senseonics, Incorporated on under FDA product code SBA (Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate). FDA's definition for product code SBA reads: "An integrated continuous glucose monitoring system (iCGM) with sensor containing dexamethasone acetate is intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems...". FDA records list 2 510(k) clearances for Senseonics, Incorporated, from to . As of , FDA records show no recalls naming K241335.

Clearance record

Decision date
Received
(126 days to decision)
Product code
SBA Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
Regulation
21 CFR 862.1357
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Senseonics, Incorporated 20451 Seneca Meadows Pkwy., Germantown MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBA

Trailing 12 months

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

FDA records show no clearances under product code SBA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBA, 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