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 Animas Corp..

85
Total
85
Cleared
133d
Avg days
1989
Since
85 devices
25–48 of 85
Cleared Mar 29, 2012
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
K120206
Medtronic Minimed
General Hospital · 66d
Cleared Dec 15, 2011
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
K111669
Insulet Corporation
General Hospital · 183d
Cleared Nov 09, 2011
T:SLIM (TM) INSULIN DELIVERY SYSTEM
K111210
Tandem Diabetes Care, Inc.
General Hospital · 194d
Cleared May 10, 2011
PEARL DIABETES MANAGEMENT SYSTEM
K100567
M2 Group Holdings, Inc.
General Hospital · 435d
Cleared Feb 23, 2011
V-GO INSULIN DELIVERY SYSTEM
K103825
Valeritas, Inc.
General Hospital · 55d
Cleared Dec 01, 2010
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
K100504
Valeritas, LLC
General Hospital · 282d
Cleared Jan 25, 2010
SOLO MICROPUMP INSULIN DELIVERY SYSTEM
K093364
Medingo , Ltd.
General Hospital · 89d
Cleared Jul 23, 2009
SOLO INSULIN PATCH PUMP
K090245
Medingo , Ltd.
General Hospital · 171d
Cleared Feb 20, 2009
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
K083225
Abbott Diabetes Care, Inc.
General Hospital · 109d
Cleared Dec 17, 2008
SYMPHONY METER REMOTE
K082590
Lifescan, Inc.
General Hospital · 100d
Cleared Oct 28, 2008
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K082595
Roche Diagnostics
General Hospital · 50d
Cleared Jun 24, 2008
SYMPHONY GLUCOSE MANAGEMENT SYSTEM
K080639
Animas Corp.
General Hospital · 110d
Cleared Jun 06, 2008
NILIMEDIX ADI
K070844
Nilimedix , Ltd.
General Hospital · 437d
Cleared Apr 25, 2008
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
K073356
Medtronic Minimed
General Hospital · 148d
Cleared Jan 11, 2008
AVIATOR INSULIN PUMP
K071788
Abbott Diabetes Care, Inc.
General Hospital · 193d
Cleared Dec 14, 2007
AMIGO INSULIN PUMP
K071613
Nipro Diabetes Systems, Inc.
General Hospital · 184d
Cleared Mar 30, 2007
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
K063674
Animas Corp.
General Hospital · 109d
Cleared Feb 02, 2007
DANA DIABECARE IIS
K063126
Sooil Development Co., Ltd.
General Hospital · 112d
Cleared Nov 01, 2006
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
K062323
Smiths Medical MD, Inc.
General Hospital · 84d
Cleared Jun 15, 2006
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001
K060876
Disetronic Medical Systems AG
General Hospital · 76d
Cleared Jan 31, 2006
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
K053177
Medtronic Minimed
General Hospital · 78d
Cleared Dec 23, 2005
INSULIN PUMP
K051041
Abbott Diabetes Care, Inc.
General Hospital · 242d
Cleared Sep 13, 2005
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
K050760
Roche Diagnostics Corp.
General Hospital · 173d
Cleared Aug 16, 2005
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
K050971
Biovalve Technologies, Inc.
General Hospital · 120d