LZG · Class II · 21 CFR 880.5725

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 Tandem Diabetes Care, Inc..

84
Total
84
Cleared
133d
Avg days
1989
Since
Declining activity - 1 submissions in the last 2 years vs 3 in the prior period
Consistent review times: 146d avg (recent)

FDA 510(k) Cleared Pump, Infusion, Insulin Devices (Product Code LZG)

84 devices
1–24 of 84
Cleared Apr 08, 2026
Pivot Insulin Delivery System
K253534
Modular Medical
Chemistry · 146d
Cleared Sep 04, 2024
Modular Medical MODD1 Insulin Delivery System
K240158
Modular Medical, Inc.
Chemistry · 229d
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 Apr 06, 2022
Extended Reservoir
K210714
Medtronic Minimed, Inc.
Chemistry · 392d
Cleared Aug 13, 2021
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
K211575
Insulet Corporation
Chemistry · 84d
Cleared Oct 21, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K192659
Insulet Corporation
General Hospital · 26d
Cleared Jan 08, 2019
Omnipod Insulin Management System, Omnipod DASH Insulin Management System
K182630
Insulet Corporation
General Hospital · 106d
Cleared Jun 01, 2018
Omnipod DASH Insulin Management System
K180045
Insulet Corporation
General Hospital · 144d
Cleared Apr 18, 2017
OmniPod Insulin Management System
K162296
Insulet Corporation
General Hospital · 245d
Cleared Oct 25, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K162080
Tandem Diabetes Care, Inc.
General Hospital · 90d
Cleared Jul 25, 2016
t:slim Insulin Delivery System
K160056
Tandem Diabetes Care, Inc.
General Hospital · 195d
Cleared Jul 13, 2016
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
K160482
Tandem Diabetes Care, Inc.
General Hospital · 142d
Cleared Apr 27, 2016
OmniPod Insulin Management System
K160252
Insulet Corporation
General Hospital · 86d
Cleared Jan 09, 2015
t:flex Insulin Delivery System
K143189
Tandem Diabetes Care, Inc.
General Hospital · 65d
Cleared Dec 18, 2014
Snap Insulin Pump System
K142619
Asante Solutions, Inc.
General Hospital · 93d
Cleared Nov 13, 2014
OMNIPOD INSULIN MANAGEMENT SYSTEM
K140439
Insulet Corporation
General Hospital · 265d
Cleared Oct 31, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K141758
Tandem Diabetes Care, Inc.
General Hospital · 123d
Cleared Mar 24, 2014
T:SLIM INSULIN DELIVERY SYSTEM
K133593
Tandem Diabetes Care, Inc.
General Hospital · 122d
Cleared Aug 29, 2013
OMNIPOD INSULIN MANAGEMENT SYSTEM
K131294
Insulet Corporation
General Hospital · 115d
Cleared Jan 03, 2013
PEARL DIABETES MANAGEMENT SYSTEM
K122483
Asante Solutions, Inc.
General Hospital · 142d
Cleared Dec 07, 2012
OMNIPOD INSULIN MANAGMENT SYSTEM
K122953
Insulet Corporation
General Hospital · 73d
Cleared Jul 17, 2012
ACCU-CHECK COMBO SYSTEM
K111353
Roche Diagnostics
General Hospital · 428d
Cleared Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206
Medtronic Minimed
General Hospital · 66d

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 declined in recent years - 1 submissions in the last 24 months compared to 3 in the prior period.

FDA 510(k) Review Time - LZG Product Code

FDA review times for LZG submissions have been consistent, averaging 146 days recently vs 133 days historically.

LZG devices are reviewed by the General Hospital panel. Browse all General Hospital devices →