FDA Product Code LZG: Pump, Infusion, Insulin
Insulin pump therapy enables flexible, physiological insulin delivery. FDA product code LZG covers insulin infusion pumps used by people with diabetes.
These devices deliver continuous subcutaneous insulin infusion via a programmable pump connected to a small catheter, providing basal insulin delivery and enabling mealtime bolus doses. They more closely mimic physiological insulin secretion than multiple daily injections.
LZG devices are Class II medical devices, regulated under 21 CFR 880.5725 and reviewed by the FDA General Hospital panel.
Leading manufacturers include Insulet Corporation, Modular Medical, Inc. and Medtronic Minimed.
FDA 510(k) Cleared Pump, Infusion, Insulin Devices (Product Code LZG)
About Product Code LZG - Regulatory Context
510(k) Submission Activity
84 total 510(k) submissions under product code LZG since 1989, with 84 receiving FDA clearance (average review time: 133 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for LZG submissions have been consistent, averaging 134 days recently vs 133 days historically.
LZG devices are reviewed by the Chemistry panel. Browse all Chemistry devices →