510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230052Unknown

Eversense AP CGM System

Senseonics, Incorporated, Germantown MD / Direct, Unknown
FDA source (opens on fda.gov)

DEN230052 is the FDA 510(k) clearance record for Eversense AP 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 DEN230052.

Clearance record

Decision date
Received
(264 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
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