OPP

Pump, Infusion, Insulin Bolus

Product code

OPP

Device name

Pump, Infusion, Insulin Bolus

Device class

Class 2

21 CFR

21 CFR 880.5725

Medical specialty

General Hospital

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

7 (all years; only the last 3 years are listed here)

FDA classification definition

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-04-10.

3 summaries are archived here for direct download.