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
84 devices
25–48 of 84
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 Feb 23, 2011
V-GO INSULIN DELIVERY SYSTEM
K103825
Valeritas, Inc.
General Hospital · 55d
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 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 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 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
Cleared May 09, 2005
AMIGO INSULIN PUMP
K050312
Nipro Diabetes Systems, Inc.
General Hospital · 90d
Cleared Mar 18, 2005
ACCU-CHEK SPIRIT
K042887
Disetronic Medical Systems AG
General Hospital · 150d
Cleared Jan 03, 2005
IXL-II DIABETES MANAGEMENT SYSTEM
K042792
Insulet Corporation
General Hospital · 89d
Cleared Dec 10, 2004
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP
K042873
Animas Corp.
General Hospital · 53d
Cleared Dec 01, 2004
MODIFICATION TO D-TRONPLUS
K043000
Disetronic Medical Systems AG
General Hospital · 30d
Cleared Jul 19, 2004
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP
K041317
Medtronic Minimed
General Hospital · 62d
Cleared Jul 19, 2004
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP
K041318
Medtronic Minimed
General Hospital · 62d
Cleared May 27, 2004
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER
K031738
Smiths Medical MD, Inc.
General Hospital · 358d
Cleared May 21, 2004
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715
K040676
Medtronic Minimed
General Hospital · 67d
Cleared Oct 23, 2003
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333
K032164
Medtronic Minimed
General Hospital · 100d
Cleared Feb 10, 2000
R1000 SERIES INSULIN PUMP
K993184
Animas Corp.
General Hospital · 140d