FDA Product Code
FDA Product Code LZG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General Hospital
- 21 CFR Citation
- 880.5725
510(k) Clearances — 85 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262153 | Pivot Insulin Delivery System | Modular Medical, Inc. | 2026-09-02 | Traditional | PDF ↗ |
| K253534 | Pivot Insulin Delivery System | Modular Medical | 2026-04-08 | Traditional | PDF ↗ |
| K240158 | Modular Medical MODD1 Insulin Delivery System | Modular Medical, Inc. | 2024-09-04 | Traditional | PDF ↗ |
| K241622 | Extended Reservoir; MiniMed Reservoir | Medtronic Minimed | 2024-07-02 | Special | PDF ↗ |
| K223372 | Omnipod GO Insulin Delivery Device | Insulet Corporation | 2023-04-24 | Traditional | PDF ↗ |
| K210714 | Extended Reservoir | Medtronic Minimed, Inc. | 2022-04-06 | Traditional | PDF ↗ |
| K211575 | Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System | Insulet Corporation | 2021-08-13 | Traditional | PDF ↗ |
| K192659 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019-10-21 | Traditional | PDF ↗ |
| K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | Insulet Corporation | 2019-01-08 | Traditional | PDF ↗ |
| K180045 | Omnipod DASH Insulin Management System | Insulet Corporation | 2018-06-01 | Traditional | PDF ↗ |
| K162296 | OmniPod Insulin Management System | Insulet Corporation | 2017-04-18 | Traditional | PDF ↗ |
| K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | 2016-10-25 | Traditional | PDF ↗ |
| K160056 | t:slim Insulin Delivery System | Tandem Diabetes Care, Inc. | 2016-07-25 | Traditional | PDF ↗ |
| K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater | Tandem Diabetes Care, Inc. | 2016-07-13 | Traditional | PDF ↗ |
| K160252 | OmniPod Insulin Management System | Insulet Corporation | 2016-04-27 | Traditional | PDF ↗ |
| K143189 | t:flex Insulin Delivery System | Tandem Diabetes Care, Inc. | 2015-01-09 | Traditional | PDF ↗ |
| K142619 | Snap Insulin Pump System | Asante Solutions, Inc. | 2014-12-18 | Special | PDF ↗ |
| K140439 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2014-11-13 | Traditional | PDF ↗ |
| K141758 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-10-31 | Traditional | PDF ↗ |
| K133593 | T:SLIM INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2014-03-24 | Special | PDF ↗ |
| K131294 | OMNIPOD INSULIN MANAGEMENT SYSTEM | Insulet Corporation | 2013-08-29 | Traditional | PDF ↗ |
| K122483 | PEARL DIABETES MANAGEMENT SYSTEM | Asante Solutions, Inc. | 2013-01-03 | Special | PDF ↗ |
| K122953 | OMNIPOD INSULIN MANAGMENT SYSTEM | Insulet Corporation | 2012-12-07 | Traditional | PDF ↗ |
| K111353 | ACCU-CHECK COMBO SYSTEM | Roche Diagnostics | 2012-07-17 | Abbreviated | PDF ↗ |
| K120206 | MEDTRONIC MINIMED PARADIGM INSULIN PUMPS | Medtronic Minimed | 2012-03-29 | Special | PDF ↗ |
| K111669 | FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS | Insulet Corporation | 2011-12-15 | Traditional | PDF ↗ |
| K111210 | T:SLIM (TM) INSULIN DELIVERY SYSTEM | Tandem Diabetes Care, Inc. | 2011-11-09 | Traditional | PDF ↗ |
| K100567 | PEARL DIABETES MANAGEMENT SYSTEM | M2 Group Holdings, Inc. | 2011-05-10 | Traditional | PDF ↗ |
| K103825 | V-GO INSULIN DELIVERY SYSTEM | Valeritas, Inc. | 2011-02-23 | Traditional | PDF ↗ |
| K100504 | V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 | Valeritas, LLC | 2010-12-01 | Traditional | PDF ↗ |
| K093364 | SOLO MICROPUMP INSULIN DELIVERY SYSTEM | Medingo , Ltd. | 2010-01-25 | Traditional | PDF ↗ |
| K090245 | SOLO INSULIN PATCH PUMP | Medingo , Ltd. | 2009-07-23 | Traditional | PDF ↗ |
| K083225 | FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM | Abbott Diabetes Care, Inc. | 2009-02-20 | Traditional | PDF ↗ |
| K082590 | SYMPHONY METER REMOTE | Lifescan, Inc. | 2008-12-17 | Traditional | PDF ↗ |
| K082595 | MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE | Roche Diagnostics | 2008-10-28 | Special | PDF ↗ |
| K080639 | SYMPHONY GLUCOSE MANAGEMENT SYSTEM | Animas Corp. | 2008-06-24 | Traditional | PDF ↗ |
| K070844 | NILIMEDIX ADI | Nilimedix , Ltd. | 2008-06-06 | Traditional | PDF ↗ |
| K073356 | PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 | Medtronic Minimed | 2008-04-25 | Special | PDF ↗ |
| K071788 | AVIATOR INSULIN PUMP | Abbott Diabetes Care, Inc. | 2008-01-11 | Traditional | PDF ↗ |
| K071613 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | 2007-12-14 | Traditional | PDF ↗ |
| K063674 | EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE | Animas Corp. | 2007-03-30 | Traditional | PDF ↗ |
| K063126 | DANA DIABECARE IIS | Sooil Development Co., Ltd. | 2007-02-02 | Special | PDF ↗ |
| K062323 | DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 | Smiths Medical MD, Inc. | 2006-11-01 | Special | PDF ↗ |
| K060876 | ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA | Disetronic Medical Systems AG | 2006-06-15 | Traditional | PDF ↗ |
| K053177 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E | Medtronic Minimed | 2006-01-31 | Traditional | PDF ↗ |
| K051041 | INSULIN PUMP | Abbott Diabetes Care, Inc. | 2005-12-23 | Traditional | PDF ↗ |
| K050760 | ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE | Roche Diagnostics Corp. | 2005-09-13 | Traditional | PDF ↗ |
| K050971 | BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) | Biovalve Technologies, Inc. | 2005-08-16 | Traditional | PDF ↗ |
| K050312 | AMIGO INSULIN PUMP | Nipro Diabetes Systems, Inc. | 2005-05-09 | Traditional | PDF ↗ |
| K042887 | ACCU-CHEK SPIRIT | Disetronic Medical Systems AG | 2005-03-18 | Traditional | PDF ↗ |
| K042792 | IXL-II DIABETES MANAGEMENT SYSTEM | Insulet Corporation | 2005-01-03 | Traditional | PDF ↗ |
| K042873 | ANIMAS MODEL IR1250 INSULIN INFUSION PUMP | Animas Corp. | 2004-12-10 | Traditional | PDF ↗ |
| K043000 | MODIFICATION TO D-TRONPLUS | Disetronic Medical Systems AG | 2004-12-01 | Special | PDF ↗ |
| K041318 | MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP | Medtronic Minimed | 2004-07-19 | Special | PDF ↗ |
| K041317 | MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP | Medtronic Minimed | 2004-07-19 | Special | PDF ↗ |
| K031738 | SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER | Smiths Medical MD, Inc. | 2004-05-27 | Traditional | PDF ↗ |
| K040676 | MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 | Medtronic Minimed | 2004-05-21 | Traditional | PDF ↗ |
| K031373 | IXL DIABETES MANAGEMENT SYSTEM | Insulet Corp. | 2003-12-19 | Traditional | PDF ↗ |
| K031541 | PARADIGMPAL, MODEL MMT-7330 | Minimed, Inc. | 2003-11-18 | Traditional | PDF ↗ |
| K032164 | DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 | Medtronic Minimed | 2003-10-23 | Traditional | PDF ↗ |
| K032257 | MODEL IR 1200 INSULIN PUMP | Animas Corp. | 2003-10-16 | Traditional | PDF ↗ |
| K030531 | MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER | Minimed, Inc. | 2003-06-17 | Traditional | PDF ↗ |
| K022394 | EZMANAGER PLUS | Animas Corp. | 2003-06-05 | Traditional | PDF ↗ |
| K023471 | DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP | Disetronic Medical Systems AG | 2002-10-29 | Special | PDF ↗ |
| K022831 | MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP | Disetronic Medical Systems AG | 2002-09-11 | Special | PDF ↗ |
| K020655 | DELTEC INSULIN INFUSION PUMP AND ACCESSORIES | Deltec, Inc. | 2002-08-13 | Traditional | PDF ↗ |
| K021725 | DISETRONIC D-TRON INSULIN INFUSION PUMP | Disetronic Medical Systems AG | 2002-08-02 | Special | PDF ↗ |
| K022317 | DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS | Sooil Development Co., Ltd. | 2002-08-02 | Special | PDF ↗ |
| K013309 | GLUCOPRO EVO INFUSION PUMP | Nipro Diabetes Systems, Inc. | 2002-06-24 | Traditional | PDF ↗ |
| K021439 | MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO | Animas Corp. | 2002-05-29 | Special | PDF ↗ |
| K013807 | MICROJET QUARK, MODEL U100 OR U40 | Cane S.R.L. | 2001-12-12 | Traditional | PDF ↗ |
| K001604 | DANA DIABECARE | Sooil Development Co., Ltd. | 2000-08-14 | Traditional | PDF ↗ |
| K993184 | R1000 SERIES INSULIN PUMP | Animas Corp. | 2000-02-10 | Traditional | PDF ↗ |
| K994186 | DISETRONIC D-TRON INSULIN INFUSION PUMP | Disetronic Medical Systems | 1999-12-30 | Special | PDF ↗ |
| K993012 | MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 | Medtronic Minimed | 1999-11-15 | Traditional | PDF ↗ |
| K991376 | DAHEDI INSULIN INFUSION PUMP | Disetronic Medical Systems | 1999-06-15 | Traditional | PDF ↗ |
| K990801 | MINIMED 508 INSULIN PUMP | Medtronic Minimed | 1999-06-08 | Traditional | PDF ↗ |
| K973044 | DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP | Disetronic Medical Systems | 1997-09-15 | Traditional | PDF ↗ |
| K972107 | MINIMED INFUSION PUMP, MODEL 507C | Medtronic Minimed | 1997-08-15 | Traditional | PDF ↗ |
| K963948 | MINIMED INSULIN PUMP, MODEL 505 | Medtronic Minimed | 1997-04-08 | Traditional | PDF ↗ |
| K960001 | MINIMED INFUSION PUMP, MODEL MMT-507 | Medtronic Minimed | 1996-04-30 | Traditional | PDF ↗ |
| K905693 | H-TRON V 100 INSULIN INFUSION PUMP | Disetronic Medical Systems | 1991-04-12 | Traditional | PDF ↗ |
| K901588 | MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP | Medtronic Minimed | 1990-07-02 | Traditional | PDF ↗ |
| K900498 | MODIFIED BETATRON IV INSULIN INFUSION SYSTEM | Cardiac Pacemakers, Inc. | 1990-02-23 | Traditional | PDF ↗ |
| K884978 | PHARMA-PLAST INSULIN INFUSION SET | Pharma-Plast USA, Inc. | 1989-06-21 | Traditional | PDF ↗ |
Product code LZG · Class II · General Hospital. Data: openFDA.