ClearanceBrief
Panels › General Hospital › Product code LZG · Class 2

Pump, Infusion, Insulin

Regulation 880.5725

2510(k)s in 12 months (85 all time)
3recalls in 12 months (126 all time)
96recalls that name a 510(k)
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Top companies in LZG

Company510(k)sRecalls
Disetronic Medical Systems1033
Animas Corp.725
Medtronic Minimed1517
Insulet Corp.1314
Roche Diagnostics312
Smiths Medical MD, Inc.28
Tandem Diabetes Care, Inc.71
Valeritas, Inc.25
Nipro Diabetes Systems, Inc.31
Abbott Diabetes Care, Inc.30
Decided510(k)Device and applicantCode
Sep 2, 2026K262153Pivot Insulin Delivery System
Modular Medical, Inc.
LZG
Apr 8, 2026K253534Pivot Insulin Delivery System
Modular Medical
LZG
Sep 4, 2024K240158Modular Medical MODD1 Insulin Delivery System
Modular Medical, Inc.
LZG
Jul 2, 2024K241622Extended Reservoir; MiniMed Reservoir
Medtronic Minimed
LZG
Apr 24, 2023K223372Omnipod GO Insulin Delivery Device
Insulet Corporation
LZG
Apr 6, 2022K210714Extended Reservoir
Medtronic Minimed, Inc.
LZG
Aug 13, 2021K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System
Insulet Corporation
LZG
Oct 21, 2019K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation
LZG
Jan 8, 2019K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation
LZG
Jun 1, 2018K180045Omnipod DASH Insulin Management System
Insulet Corporation
LZG
Apr 18, 2017K162296OmniPod Insulin Management System
Insulet Corporation
LZG
Oct 25, 2016K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Tandem Diabetes Care, Inc.
LZG
Jul 25, 2016K160056t:slim Insulin Delivery System
Tandem Diabetes Care, Inc.
LZG
Jul 13, 2016K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater
Tandem Diabetes Care, Inc.
LZG
Apr 27, 2016K160252OmniPod Insulin Management System
Insulet Corporation
LZG
Jan 9, 2015K143189t:flex Insulin Delivery System
Tandem Diabetes Care, Inc.
LZG
Dec 18, 2014K142619Snap Insulin Pump System
Asante Solutions, Inc.
LZG
Nov 13, 2014K140439OMNIPOD INSULIN MANAGEMENT SYSTEM
Insulet Corporation
LZG
Oct 31, 2014K141758T:SLIM INSULIN DELIVERY SYSTEM
Tandem Diabetes Care, Inc.
LZG
Mar 24, 2014K133593T:SLIM INSULIN DELIVERY SYSTEM
Tandem Diabetes Care, Inc.
LZG
Aug 29, 2013K131294OMNIPOD INSULIN MANAGEMENT SYSTEM
Insulet Corporation
LZG
Jan 3, 2013K122483PEARL DIABETES MANAGEMENT SYSTEM
Asante Solutions, Inc.
LZG
Dec 7, 2012K122953OMNIPOD INSULIN MANAGMENT SYSTEM
Insulet Corporation
LZG
Jul 17, 2012K111353ACCU-CHECK COMBO SYSTEM
Roche Diagnostics
LZG
Mar 29, 2012K120206MEDTRONIC MINIMED PARADIGM INSULIN PUMPS
Medtronic Minimed
LZG
Dec 15, 2011K111669FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
Insulet Corporation
LZG
Nov 9, 2011K111210T:SLIM (TM) INSULIN DELIVERY SYSTEM
Tandem Diabetes Care, Inc.
LZG
May 10, 2011K100567PEARL DIABETES MANAGEMENT SYSTEM
M2 Group Holdings, Inc.
LZG
Feb 23, 2011K103825V-GO INSULIN DELIVERY SYSTEM
Valeritas, Inc.
LZG
Dec 1, 2010K100504V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40
Valeritas, LLC
LZG
Jan 25, 2010K093364SOLO MICROPUMP INSULIN DELIVERY SYSTEM
Medingo , Ltd., IL
LZG
Jul 23, 2009K090245SOLO INSULIN PATCH PUMP
Medingo , Ltd., IL
LZG
Feb 20, 2009K083225FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM
Abbott Diabetes Care, Inc.
LZG
Dec 17, 2008K082590SYMPHONY METER REMOTE
Lifescan, Inc.
LZG
Oct 28, 2008K082595MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics
LZG
Jun 24, 2008K080639SYMPHONY GLUCOSE MANAGEMENT SYSTEM
Animas Corp.
LZG
Jun 6, 2008K070844NILIMEDIX ADI
Nilimedix , Ltd., IL
LZG
Apr 25, 2008K073356PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715
Medtronic Minimed
LZG
Jan 11, 2008K071788AVIATOR INSULIN PUMP
Abbott Diabetes Care, Inc.
LZG
Dec 14, 2007K071613AMIGO INSULIN PUMP
Nipro Diabetes Systems, Inc.
LZG
Mar 30, 2007K063674EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE
Animas Corp.
LZG
Feb 2, 2007K063126DANA DIABECARE IIS
Sooil Development Co., Ltd.
LZG
Nov 1, 2006K062323DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817
Smiths Medical MD, Inc.
LZG
Jun 15, 2006K060876ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA
Disetronic Medical Systems AG
LZG
Jan 31, 2006K053177MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E
Medtronic Minimed
LZG
Dec 23, 2005K051041INSULIN PUMP
Abbott Diabetes Care, Inc.
LZG
Sep 13, 2005K050760ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE
Roche Diagnostics Corp.
LZG
Aug 16, 2005K050971BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)
Biovalve Technologies, Inc.
LZG
May 9, 2005K050312AMIGO INSULIN PUMP
Nipro Diabetes Systems, Inc.
LZG
Mar 18, 2005K042887ACCU-CHEK SPIRIT
Disetronic Medical Systems AG, CH
LZG

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