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

DateFirm and productCodeLinked 510(k)
Jun 30, 2026Insulet Corporation
Omnipod (Eros) Pod. Includes the below Model/REF Numbers: 1. POD-ZXP425 (10 Pack), POD- ZXP420 (Single Pod). 2. ZXR425 (10-Pack), ZXR420 (Single Pod). 3. ZXP425 (10 Pack), ZXP420 (Single Pod).
Open, Classified
LZGK211575
Jun 30, 2026Insulet Corporation
Omnipod DASH Pod. Includes the below Model/REF Numbers: 1. POD-BLE-I1-525 (5-Pack), POD-BLE-I1-520 (Single Pod). 2. POD-BLE-I1-529 (10-Pack), POD-BLE-I1-520 (Single Pod). 3. BLE-I1-529 (10-Pack)
Open, Classified
LZGK211575
Apr 2, 2026Medtronic MiniMed, Inc.
Paradigm Insulin Pump (MMT-712, MMT-715)
Open, Classified
LZGK031390
K040676 +2
Mar 3, 2025Medtronic MiniMed, Inc.
Paradigm REF: MMT-712 and MMT-715
Open, Classified
LZGK053177
K120206
Nov 15, 2022Insulet Corporation
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote C
Terminated
LZGK211575
Jul 28, 2021Roche Diabetes Care, Inc.
Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001
Open, Classified
LZGK131029
Feb 1, 2021Insulet Corporation
Omnipod DASH Insulin Management System User Guide (OUS Only) Product Catalog Number: PT 000002 XXX XXX XX PT 000318 PT 000319 Distributed to: Canada (French only), the Netherlands, France, Austria,
Terminated
LZGK192659
Apr 2, 2020Insulet Corporation
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for
Terminated
LZGK192659
Apr 2, 2020Insulet Corporation
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for t
Terminated
LZGK192659
Mar 26, 2020Medtronic MiniMed
Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715
Open, Classified
LZGK120206
Mar 26, 2020Medtronic MiniMed
Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E
Open, Classified
LZGK053177
Mar 26, 2020Medtronic MiniMed
MiniMed Paradigm Insulin pump, model number MMT-712
Open, Classified
LZGK120206
Mar 26, 2020Medtronic MiniMed
MiniMed Paradigm 512 Insulin pump
Open, Classified
LZGK120206
Mar 26, 2020Medtronic MiniMed
MiniMed Paradigm Model 511 Insulin Pump
Open, Classified
LZGK041318
Mar 26, 2020Medtronic MiniMed
MiniMed Insulin Pump, model # MMT-508
Open, Classified
LZGK990801
Feb 13, 2020Insulet Corporation
Omnipod DASH Personal Diabetes Manager (PDM), Catalog numbers US: 18239 M/D: PDM-USA1-D001-MG-USA1 EU: PT-000010 - M/D: INT1-D001-MG PT-000011 M/D: INT1-D001-MM UDI 10385082000009 The Om
Terminated
LZGK192659
Nov 4, 2019Medtronic Inc.
Minimed Model 503 Remote Transmitter (MMT-503, MMT-503EU, MMT-503NA, MMT-503US) for use with the MiniMed Paradigm Insulin Pump (MMT-523/723, MMT-523K/723K, MMT-551/751, MMT-554/754, MMT-522/722, MMT-5
Terminated
LZGK001829
K120206
Nov 4, 2019Medtronic Inc.
Minimed Model 500 Remote Control (MMT-500, MMT-500RU, MMT-500RUS, MMT-500RSE, MMT-500RCH, MMT-500RDE, MMT-500REU, MMT-500RFR, MMT-500RGB, MMT-500RIL, MMT-500RNL) for use with the MiniMed 508 Insulin P
Terminated
LZGK990801
Jul 3, 2019Valeritas, Incorporated
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02
Terminated
LZGK103825
Jul 3, 2019Valeritas, Incorporated
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03
Terminated
LZGK103825
Jul 3, 2019Valeritas, Incorporated
DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01
Terminated
LZGK103825
Jul 3, 2019Valeritas, Incorporated
DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02
Terminated
LZGK103825
Jul 3, 2019Valeritas, Incorporated
DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03
Terminated
LZGK103825
Dec 18, 2018Insulet Corporation
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Terminated
LZGK180045
Dec 15, 2015Insulet Corporation
OmniPod, Insulin Management System (OUS) Catalog Number: 14810 Product Usage: The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for th
Terminated
LZGK122953
Dec 15, 2015Insulet Corporation
OmniPod, Insulin Management System (US) Catalog Number: PODZXP420 Product Usage: The OmnniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for
Terminated
LZGK122953
Sep 10, 2015Elcam Medical, Inc.
Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring and intravenous fluid administration. Manufactured by: Elcam Medical ACAL, Israel; Distributed by: Elcam Medical Inc., US
Terminated
LZGK122953
Sep 10, 2015Elcam Medical, Inc.
Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quan
Terminated
LZGK122953
Sep 4, 2015Insulet Corporation
OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): 14810 (OUS). Intended for subcutaneous delivery of insulin at set and variable rates for the management of
Terminated
LZGK122953
Sep 4, 2015Insulet Corporation
OmniPod Insulin Management System. Only the OmniPod device is affected. Catalog Number(s): POD-ZXP420 (US). Intended for subcutaneous delivery of insulin at set and variable rates for the management
Terminated
LZGK122953
Jun 9, 2015Roche Diabetes Care, Inc.
AccuChek Spirit insulin infusion pump.
Terminated
LZGK042887
Jun 9, 2015Roche Diabetes Care, Inc.
AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.
Terminated
LZGK111353
Mar 2, 2015Medtronic MiniMed Inc.
CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and bloo
Terminated
LZGNone listed
Oct 29, 2014Roche Diagnostics Operations, Inc.
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is meant only for single-patient use; the device may not be used for scre
Terminated
LZGK111353
Oct 24, 2014Animas Corporation
Animas Vibe Insulin Infusion Pump and System. These products are indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Terminated
LZGNone listed
Feb 10, 2014Tandem Diabetes Care Inc
T:slim Insulin Delivery System Insulin Infusion Pump
Terminated
LZGK111210
Nov 5, 2013Insulet Corporation
OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by heal
Terminated
LZGK122953
Nov 5, 2013Insulet Corporation
OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Ins
Terminated
LZGK122953
Apr 3, 2013Animas Corporation
Animas(R) 2020 Insulin Infusion Pump Product Usage: This product is indicated for continuous subcutaneous infusion of insulin for the treatment of insulin-requiring diabetes.
Terminated
LZGK042873
Feb 17, 2013Animas Corporation
Animas(R) 2020, Animas(R) IR 1250 (1200 plus), Animas(R) IR 1200 Insulin Infusion Pumps Indicated for continuous subcutaneous infusion of insulin.
Terminated
LZGK032257
K042873
Oct 2, 2012Animas Corporation
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Terminated
LZGK032257
Apr 6, 2012Animas Corporation
OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Terminated
LZGK080639
Aug 12, 2011Animas Corporation
Animas 2020 Insulin Infusion Pump. Animas Corp. An insulin infusion.
Terminated
LZGNone listed
May 10, 2011Animas Corporation
2.0 mL Cartridge/Syringe Piston component of Insulin Pump Insulin infusion
Terminated
LZGK032257
Sep 10, 2010Animas Corporation
Animas IR 1250 (1200 plus) Intended use:deliver insulin therapy
Terminated
LZGNone listed
Sep 10, 2010Animas Corporation
Animas IR 1200 Intended use:deliver insulin therapy
Terminated
LZGK032257
Sep 10, 2010Animas Corporation
Animas 2020 Insulin Infusion Pumps Intended use:deliver insulin therapy
Terminated
LZGNone listed
Sep 10, 2010Animas Corporation
One Touch Ping Glucose Management Systems Intended use: deliver insulin therapy
Terminated
LZGK080639
May 8, 2010Animas Corporation
One Touch Ping Insulin Pump using ezManager Max diabetes management software
Terminated
LZGK080639
May 26, 2009Disetronic Medical Systems, Inc.
Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001.
Terminated
LZGK060876

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