FDA 510(k) Applications for Medical Device Product Code "LZG"
(Pump, Infusion, Insulin)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K071788 | ABBOTT DIABETES CARE INC. | AVIATOR INSULIN PUMP | 01/11/2008 |
| K083225 | ABBOTT DIABETES CARE INC. | FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM | 02/20/2009 |
| K051041 | ABBOTT DIABETES CARE INC. | INSULIN PUMP | 12/23/2005 |
| K042873 | ANIMAS CORP. | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP | 12/10/2004 |
| K063674 | ANIMAS CORP. | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | 03/30/2007 |
| K022394 | ANIMAS CORP. | EZMANAGER PLUS | 06/05/2003 |
| K032257 | ANIMAS CORP. | MODEL IR 1200 INSULIN PUMP | 10/16/2003 |
| K021439 | ANIMAS CORP. | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO | 05/29/2002 |
| K993184 | ANIMAS CORP. | R1000 SERIES INSULIN PUMP | 02/10/2000 |
| K080639 | ANIMAS CORP. | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | 06/24/2008 |
| K142619 | ASANTE SOLUTIONS, INC | Snap Insulin Pump System | 12/18/2014 |
| K122483 | Asante Solutions, Inc. | PEARL DIABETES MANAGEMENT SYSTEM | 01/03/2013 |
| K050971 | BIOVALVE TECHNOLOGIES, INC. | BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) | 08/16/2005 |
| K013807 | CANE SRL | MICROJET QUARK, MODEL U100 OR U40 | 12/12/2001 |
| K020655 | DELTEC, INC. | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES | 08/13/2002 |
| K991376 | DISETRONIC MEDICAL SYSTEMS | DAHEDI INSULIN INFUSION PUMP | 06/15/1999 |
| K994186 | DISETRONIC MEDICAL SYSTEMS | DISETRONIC D-TRON INSULIN INFUSION PUMP | 12/30/1999 |
| K973044 | DISETRONIC MEDICAL SYSTEMS | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP | 09/15/1997 |
| K060876 | DISETRONIC MEDICAL SYSTEMS AG | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA | 06/15/2006 |
| K042887 | DISETRONIC MEDICAL SYSTEMS AG | ACCU-CHEK SPIRIT | 03/18/2005 |
| K021725 | DISETRONIC MEDICAL SYSTEMS AG | DISETRONIC D-TRON INSULIN INFUSION PUMP | 08/02/2002 |
| K023471 | DISETRONIC MEDICAL SYSTEMS AG | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP | 10/29/2002 |
| K043000 | DISETRONIC MEDICAL SYSTEMS AG | MODIFICATION TO D-TRONPLUS | 12/01/2004 |
| K022831 | DISETRONIC MEDICAL SYSTEMS AG | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP | 09/11/2002 |
| K031373 | INSULET CORP. | IXL DIABETES MANAGEMENT SYSTEM | 12/19/2003 |
| K111669 | INSULET CORPORATION | FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS | 12/15/2011 |
| K042792 | INSULET CORPORATION | IXL-II DIABETES MANAGEMENT SYSTEM | 01/03/2005 |
| K180045 | Insulet Corporation | Omnipod DASH Insulin Management System | 06/01/2018 |
| K223372 | Insulet Corporation | Omnipod GO Insulin Delivery Device | 04/24/2023 |
| K160252 | INSULET CORPORATION | OmniPod Insulin Management System | 04/27/2016 |
| K162296 | INSULET CORPORATION | OmniPod Insulin Management System | 04/18/2017 |
| K131294 | INSULET CORPORATION | OMNIPOD INSULIN MANAGEMENT SYSTEM | 08/29/2013 |
| K140439 | INSULET CORPORATION | OMNIPOD INSULIN MANAGEMENT SYSTEM | 11/13/2014 |
| K192659 | Insulet Corporation | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | 10/21/2019 |
| K182630 | Insulet Corporation | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | 01/08/2019 |
| K122953 | INSULET CORPORATION | OMNIPOD INSULIN MANAGMENT SYSTEM | 12/07/2012 |
| K211575 | Insulet Corporation | Omnipod« Insulin Management System, Omnipod DASH« Insulin Management System | 08/13/2021 |
| K082590 | LIFESCAN, INC. | SYMPHONY METER REMOTE | 12/17/2008 |
| K100567 | M2 GROUP HOLDINGS, INC. | PEARL DIABETES MANAGEMENT SYSTEM | 05/10/2011 |
| K090245 | MEDINGO LTD. | SOLO INSULIN PATCH PUMP | 07/23/2009 |
| K093364 | MEDINGO LTD. | SOLO MICROPUMP INSULIN DELIVERY SYSTEM | 01/25/2010 |
| K032164 | MEDTRONIC MINIMED | DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 | 10/23/2003 |
| K053177 | MEDTRONIC MINIMED | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E | 01/31/2006 |
| K040676 | MEDTRONIC MINIMED | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 | 05/21/2004 |
| K120206 | MEDTRONIC MINIMED | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS | 03/29/2012 |
| K041318 | MEDTRONIC MINIMED | MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP | 07/19/2004 |
| K990801 | MEDTRONIC MINIMED | MINIMED 508 INSULIN PUMP | 06/08/1999 |
| K993012 | MEDTRONIC MINIMED | MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 | 11/15/1999 |
| K972107 | MEDTRONIC MINIMED | MINIMED INFUSION PUMP, MODEL 507C | 08/15/1997 |
| K960001 | MEDTRONIC MINIMED | MINIMED INFUSION PUMP, MODEL MMT-507 | 04/30/1996 |
| K963948 | MEDTRONIC MINIMED | MINIMED INSULIN PUMP, MODEL 505 | 04/08/1997 |
| K041317 | MEDTRONIC MINIMED | MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP | 07/19/2004 |
| K073356 | MEDTRONIC MINIMED | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 | 04/25/2008 |
| K210714 | Medtronic MiniMed, Inc. | Extended Reservoir | 04/06/2022 |
| K030531 | MINIMED, INC. | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER | 06/17/2003 |
| K031541 | MINIMED, INC. | PARADIGMPAL, MODEL MMT-7330 | 11/18/2003 |
| K070844 | NILIMEDIX LTD. | NILIMEDIX ADI | 06/06/2008 |
| K071613 | NIPRO DIABETES SYSTEMS, INC. | AMIGO INSULIN PUMP | 12/14/2007 |
| K050312 | NIPRO DIABETES SYSTEMS, INC. | AMIGO INSULIN PUMP | 05/09/2005 |
| K013309 | NIPRO DIABETES SYSTEMS, INC. | GLUCOPRO EVO INFUSION PUMP | 06/24/2002 |
| K111353 | Roche Diagnostics | ACCU-CHECK COMBO SYSTEM | 07/17/2012 |
| K082595 | Roche Diagnostics | MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE | 10/28/2008 |
| K050760 | ROCHE DIAGNOSTICS CORP. | ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE | 09/13/2005 |
| K062323 | SMITHS MEDICAL MD, INC. | DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 | 11/01/2006 |
| K031738 | SMITHS MEDICAL MD, INC. | SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER | 05/27/2004 |
| K001604 | SOOIL DEVELOPMENT CO., LTD. | DANA DIABECARE | 08/14/2000 |
| K022317 | SOOIL DEVELOPMENT CO., LTD. | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS | 08/02/2002 |
| K063126 | SOOIL DEVELOPMENT CO., LTD. | DANA DIABECARE IIS | 02/02/2007 |
| K143189 | Tandem Diabetes Care, Inc. | t:flex Insulin Delivery System | 01/09/2015 |
| K111210 | TANDEM DIABETES CARE, INC. | T:SLIM (TM) INSULIN DELIVERY SYSTEM | 11/09/2011 |
| K160056 | Tandem Diabetes Care, Inc. | t:slim Insulin Delivery System | 07/25/2016 |
| K133593 | TANDEM DIABETES CARE, INC. | T:SLIM INSULIN DELIVERY SYSTEM | 03/24/2014 |
| K141758 | TANDEM DIABETES CARE, INC. | T:SLIM INSULIN DELIVERY SYSTEM | 10/31/2014 |
| K160482 | Tandem Diabetes Care, Inc. | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | 07/13/2016 |
| K162080 | Tandem Diabetes Care, Inc. | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | 10/25/2016 |
| K103825 | VALERITAS, INC. | V-GO INSULIN DELIVERY SYSTEM | 02/23/2011 |
| K100504 | VALERITAS, LLC | V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 | 12/01/2010 |
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