Atlas FDA

LZG

84 FDA 510(k) clearances · Product code

109 daysmedian time to decision
263 days90th percentile
84clearances measured

FDA profile

Official device name
Pump, Infusion, Insulin
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Medical specialty
General Hospital
Adverse events (MAUDE)
2021: 31,522 · 2022: 28,225 · 2023: 21,972 · 2024: 18,228 · 2025: 12,151 · 2026: 6,200
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Pivot Insulin Delivery System (K253534)Modular Medical2026-04-08
Modular Medical MODD1 Insulin Delivery System (K240158)Modular Medical, Inc.2024-09-04
Extended Reservoir; MiniMed Reservoir (K241622)Medtronic Minimed2024-07-02
Omnipod GO Insulin Delivery Device (K223372)Insulet Corporation2023-04-24
Extended Reservoir (K210714)Medtronic Minimed, Inc.2022-04-06
Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (K211575)Insulet Corporation2021-08-13
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K192659)Insulet Corporation2019-10-21
Omnipod Insulin Management System, Omnipod DASH Insulin Management System (K182630)Insulet Corporation2019-01-08
Omnipod DASH Insulin Management System (K180045)Insulet Corporation2018-06-01
OmniPod Insulin Management System (K162296)Insulet Corporation2017-04-18
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K162080)Tandem Diabetes Care, Inc.2016-10-25
t:slim Insulin Delivery System (K160056)Tandem Diabetes Care, Inc.2016-07-25
t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Updater (K160482)Tandem Diabetes Care, Inc.2016-07-13
OmniPod Insulin Management System (K160252)Insulet Corporation2016-04-27
t:flex Insulin Delivery System (K143189)Tandem Diabetes Care, Inc.2015-01-09
Snap Insulin Pump System (K142619)Asante Solutions, Inc.2014-12-18
OMNIPOD INSULIN MANAGEMENT SYSTEM (K140439)Insulet Corporation2014-11-13
T:SLIM INSULIN DELIVERY SYSTEM (K141758)Tandem Diabetes Care, Inc.2014-10-31
T:SLIM INSULIN DELIVERY SYSTEM (K133593)Tandem Diabetes Care, Inc.2014-03-24
OMNIPOD INSULIN MANAGEMENT SYSTEM (K131294)Insulet Corporation2013-08-29
PEARL DIABETES MANAGEMENT SYSTEM (K122483)Asante Solutions, Inc.2013-01-03
OMNIPOD INSULIN MANAGMENT SYSTEM (K122953)Insulet Corporation2012-12-07
ACCU-CHECK COMBO SYSTEM (K111353)Roche Diagnostics2012-07-17
MEDTRONIC MINIMED PARADIGM INSULIN PUMPS (K120206)Medtronic Minimed2012-03-29
FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS (K111669)Insulet Corporation2011-12-15
T:SLIM (TM) INSULIN DELIVERY SYSTEM (K111210)Tandem Diabetes Care, Inc.2011-11-09
PEARL DIABETES MANAGEMENT SYSTEM (K100567)M2 Group Holdings, Inc.2011-05-10
V-GO INSULIN DELIVERY SYSTEM (K103825)Valeritas, Inc.2011-02-23
V-GO DISPOSABLE INSULIN DELIVERY DEVICE, MODEL# V-GO 20, V-GO 30, V-GO40 (K100504)Valeritas, LLC2010-12-01
SOLO MICROPUMP INSULIN DELIVERY SYSTEM (K093364)Medingo , Ltd.2010-01-25
SOLO INSULIN PATCH PUMP (K090245)Medingo , Ltd.2009-07-23
FREESTYLE AVIATOR INSULIN DELIVERY AND BLOOD GLUCOSE MONITORING SYSTEM (K083225)Abbott Diabetes Care, Inc.2009-02-20
SYMPHONY METER REMOTE (K082590)Lifescan, Inc.2008-12-17
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K082595)Roche Diagnostics2008-10-28
SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639)Animas Corp.2008-06-24
NILIMEDIX ADI (K070844)Nilimedix , Ltd.2008-06-06
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 (K073356)Medtronic Minimed2008-04-25
AVIATOR INSULIN PUMP (K071788)Abbott Diabetes Care, Inc.2008-01-11
AMIGO INSULIN PUMP (K071613)Nipro Diabetes Systems, Inc.2007-12-14
EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674)Animas Corp.2007-03-30
DANA DIABECARE IIS (K063126)Sooil Development Co., Ltd.2007-02-02
DELTEC COZMO INSULIN INFUSION PUMP WITH COZMONITOR BLOOD GLUCOSE METER, MODELS 21-1815, 21-1816, 21-1817 (K062323)Smiths Medical MD, Inc.2006-11-01
ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA (K060876)Disetronic Medical Systems AG2006-06-15
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712E (K053177)Medtronic Minimed2006-01-31
INSULIN PUMP (K051041)Abbott Diabetes Care, Inc.2005-12-23
ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE (K050760)Roche Diagnostics Corp.2005-09-13
BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) (K050971)Biovalve Technologies, Inc.2005-08-16
AMIGO INSULIN PUMP (K050312)Nipro Diabetes Systems, Inc.2005-05-09
ACCU-CHEK SPIRIT (K042887)Disetronic Medical Systems AG2005-03-18
IXL-II DIABETES MANAGEMENT SYSTEM (K042792)Insulet Corporation2005-01-03
ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873)Animas Corp.2004-12-10
MODIFICATION TO D-TRONPLUS (K043000)Disetronic Medical Systems AG2004-12-01
MEDTRONIC MINIMED PARADIGM MODEL 511 INSULIN PUMP (K041318)Medtronic Minimed2004-07-19
MODIFICATION TO MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP (K041317)Medtronic Minimed2004-07-19
SMITHS MEDICAL INSULIN INFUSION PUMP WITH COZMONITOR GLUCOSE METER (K031738)Smiths Medical MD, Inc.2004-05-27
MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODELS MMT-515 AND MMT-715 (K040676)Medtronic Minimed2004-05-21
IXL DIABETES MANAGEMENT SYSTEM (K031373)Insulet Corp.2003-12-19
PARADIGMPAL, MODEL MMT-7330 (K031541)Minimed, Inc.2003-11-18
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 (K032164)Medtronic Minimed2003-10-23
MODEL IR 1200 INSULIN PUMP (K032257)Animas Corp.2003-10-16
MEDTRONIC MINIMED PARADIGM MODEL 512 INSULIN PUMP AND THE BD PARADIGM LINK GLUCOSE METER (K030531)Minimed, Inc.2003-06-17
EZMANAGER PLUS (K022394)Animas Corp.2003-06-05
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP (K023471)Disetronic Medical Systems AG2002-10-29
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP (K022831)Disetronic Medical Systems AG2002-09-11
DELTEC INSULIN INFUSION PUMP AND ACCESSORIES (K020655)Deltec, Inc.2002-08-13
DISETRONIC D-TRON INSULIN INFUSION PUMP (K021725)Disetronic Medical Systems AG2002-08-02
DANA DIABECARE II INSULIN PUMP & SUPERLINE-EASYRELEASE, SOFT-RELEASE-ST, & SOFT-RELEASE-R INFUSION SETS (K022317)Sooil Development Co., Ltd.2002-08-02
GLUCOPRO EVO INFUSION PUMP (K013309)Nipro Diabetes Systems, Inc.2002-06-24
MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439)Animas Corp.2002-05-29
MICROJET QUARK, MODEL U100 OR U40 (K013807)Cane S.R.L.2001-12-12
DANA DIABECARE (K001604)Sooil Development Co., Ltd.2000-08-14
R1000 SERIES INSULIN PUMP (K993184)Animas Corp.2000-02-10
DISETRONIC D-TRON INSULIN INFUSION PUMP (K994186)Disetronic Medical Systems1999-12-30
MINIMED COM-STATION, HARDWARE-7301; SOFTWARE-7311 (K993012)Medtronic Minimed1999-11-15
DAHEDI INSULIN INFUSION PUMP (K991376)Disetronic Medical Systems1999-06-15
MINIMED 508 INSULIN PUMP (K990801)Medtronic Minimed1999-06-08
DISETRONIC H-TRON PLUS V 100 INSULIN INFUSION PUMP (K973044)Disetronic Medical Systems1997-09-15
MINIMED INFUSION PUMP, MODEL 507C (K972107)Medtronic Minimed1997-08-15
MINIMED INSULIN PUMP, MODEL 505 (K963948)Medtronic Minimed1997-04-08
MINIMED INFUSION PUMP, MODEL MMT-507 (K960001)Medtronic Minimed1996-04-30
H-TRON V 100 INSULIN INFUSION PUMP (K905693)Disetronic Medical Systems1991-04-12
MINIMED(R) MODEL 506 EXTERNAL INSULIN PUMP (K901588)Medtronic Minimed1990-07-02
MODIFIED BETATRON IV INSULIN INFUSION SYSTEM (K900498)Cardiac Pacemakers, Inc.1990-02-23
PHARMA-PLAST INSULIN INFUSION SET (K884978)Pharma-Plast USA, Inc.1989-06-21

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Every clearance here is in the API, with alerts when new ones post.