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
K252757Substantially Equivalent

CeQur Simplicity™ On-Demand Insulin Delivery System

CeQur SA, Horw Luzern, CH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K252757 is the FDA 510(k) clearance record for CeQur Simplicity™ On-Demand Insulin Delivery System, a class II device, cleared for Cequr SA on under FDA product code OPP (Pump, Infusion, Insulin Bolus). FDA's definition for product code OPP reads: "The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus". FDA records list 3 510(k) clearances for Cequr SA, from to . As of , FDA records show no recalls naming K252757.

Clearance record

Decision date
Received
(224 days to decision)
Product code
OPP Pump, Infusion, Insulin Bolus
Regulation
21 CFR 880.5725
Device class
Class II
Review panel
General Hospital
Applicant
Cequr SA Ebenaustrasse 10, Horw Luzern, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OPP

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