DeviceClearance

Product code OPP— General Hospital

CeQur Simplicity On-Demand Insulin Delivery System

Classification name
Pump, Infusion, Insulin Bolus
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Total cleared
7
First cleared
Most recent

FDA classification definition

“The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.”

— U.S. Food and Drug Administration, device classification record for product code OPP under 21 CFR 880.5725, via openFDA

Market context for product code OPP

FDA has cleared 7 devices under product code OPP between 2010 and 2026, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OPP

Recent clearances under product code OPP

Data sourced from openFDA. This site is unofficial and independent of the FDA.