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 Medtronic Minimed, Insulet Corporation and Abbott Diabetes Care, Inc..
84
Total
84
Cleared
133d
Avg days
1989
Since
Stable submission activity - 2 submissions in the last 2 years
Review times increasing: avg
188d
recently vs 132d historically
FDA 510(k) Cleared Pump, Infusion, Insulin Devices (Product Code LZG)
84 devices
Cleared
Apr 08, 2026
Pivot Insulin Delivery System
Modular Medical
Chemistry
146d
Cleared
Sep 04, 2024
Modular Medical MODD1 Insulin Delivery System
Modular Medical, Inc.
Chemistry
229d
Cleared
Jul 02, 2024
Extended Reservoir
Medtronic Minimed
Chemistry
27d
Cleared
Apr 24, 2023
Omnipod GO Insulin Delivery Device
Insulet Corporation
Chemistry
171d
Cleared
Apr 06, 2022
Extended Reservoir
Medtronic Minimed, Inc.
Chemistry
392d
Cleared
Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Insulet Corporation
Chemistry
84d
Cleared
Oct 21, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation
General Hospital
26d
Cleared
Jan 08, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation
General Hospital
106d
Cleared
Jun 01, 2018
Omnipod DASH Insulin Management System
Insulet Corporation
General Hospital
144d
Cleared
Jul 17, 2012
ACCU-CHECK COMBO SYSTEM
Roche Diagnostics
General Hospital
428d
Cleared
Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
Medtronic Minimed
General Hospital
66d
Cleared
Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
General Hospital
109d
Cleared
Dec 17, 2008
SYMPHONY METER REMOTE
Lifescan, Inc.
General Hospital
100d
Cleared
Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics
General Hospital
50d
Cleared
Apr 25, 2008
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
Medtronic Minimed
General Hospital
148d
Cleared
Jan 11, 2008
AVIATOR INSULIN PUMP
Abbott Diabetes Care, Inc.
General Hospital
193d
Cleared
Jan 31, 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
Medtronic Minimed
General Hospital
78d
Cleared
Dec 23, 2005
INSULIN PUMP
Abbott Diabetes Care, Inc.
General Hospital
242d
Cleared
Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics Corp.
General Hospital
173d
Cleared
Jul 19, 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
Medtronic Minimed
General Hospital
62d
Cleared
Jul 19, 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
Medtronic Minimed
General Hospital
62d
Cleared
May 21, 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
Medtronic Minimed
General Hospital
67d
Cleared
Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
Medtronic Minimed
General Hospital
100d
Cleared
Nov 15, 1999
MINIMED COM-STATION, HARDWARE-7301
Medtronic Minimed
General Hospital
68d
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 remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA 510(k) Review Time - LZG Product Code
Recent submissions under LZG have taken an average of 188 days to reach a decision - up from 132 days historically. Manufacturers should account for longer review timelines in current project planning.
LZG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →