Product Code: LZG FDA class 2 21 CFR 880.5725

Pump, Infusion, Insulin

General Hospital

The Insulin Infusion Pump (product code LZG) is a programmable medical device that delivers precise subcutaneous doses of insulin continuously and on-demand to patients with diabetes, replicating the function of the pancreas in regulating blood glucose levels. Regulated under 21 CFR 880.5725 and classified as a Class 2 device, it requires a 510(k) premarket notification and falls under the General Hospital specialty with review by the Chemistry (CH) panel. It is not flagged as an implant or life-sustaining device.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code LZG in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: LZG
Device Class: FDA class 2
Regulation Number: 880.5725
Medical Specialty: General Hospital
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 84 510(k) clearances via K numbers.

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