LZG · Class II · 21 CFR 880.5725

Pump, Infusion, Insulin — FDA 510(k) Devices

3
Total
3
Cleared
94d
Avg days
2021
Since

List of Pump, Infusion, Insulin devices cleared through 510(k)

3 devices
1–3 of 3
Cleared Jul 02, 2024
Extended Reservoir
K241622
Medtronic Minimed
Chemistry · 27d
Cleared Apr 24, 2023
Omnipod GO Insulin Delivery Device
K223372
Insulet Corporation
Chemistry · 171d
Cleared Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575
Insulet Corporation
Chemistry · 84d

How to use this database

This page lists all FDA 510(k) submissions for Pump, Infusion, Insulin devices (product code LZG). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Chemistry FDA review panel. Browse all Chemistry devices →