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)
Top companies in LZG
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 30, 2026 | Insulet 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 |
LZG | K211575 |
| Jun 30, 2026 | Insulet 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 |
LZG | K211575 |
| Apr 2, 2026 | Medtronic MiniMed, Inc. Paradigm Insulin Pump (MMT-712, MMT-715) Open, Classified |
LZG | K031390 K040676 +2 |
| Mar 3, 2025 | Medtronic MiniMed, Inc. Paradigm REF: MMT-712 and MMT-715 Open, Classified |
LZG | K053177 K120206 |
| Nov 15, 2022 | Insulet 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 |
LZG | K211575 |
| Jul 28, 2021 | Roche Diabetes Care, Inc. Accu-Chek Aviva Plus Test Strip, Blood Glucose Monitoring System, Model numbers: 06908152001, 06908217001, 06908268001, 06908349001, 06908373001 Open, Classified |
LZG | K131029 |
| Feb 1, 2021 | Insulet 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 |
LZG | K192659 |
| Apr 2, 2020 | Insulet 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 |
LZG | K192659 |
| Apr 2, 2020 | Insulet 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 |
LZG | K192659 |
| Mar 26, 2020 | Medtronic MiniMed Medtronic MiniMed Paradigm Insulin pump, model numbers MMT 515 and MMT-715 Open, Classified |
LZG | K120206 |
| Mar 26, 2020 | Medtronic MiniMed Medtronic MiniMed Paradigm Insulin pump, model number MMT-712E Open, Classified |
LZG | K053177 |
| Mar 26, 2020 | Medtronic MiniMed MiniMed Paradigm Insulin pump, model number MMT-712 Open, Classified |
LZG | K120206 |
| Mar 26, 2020 | Medtronic MiniMed MiniMed Paradigm 512 Insulin pump Open, Classified |
LZG | K120206 |
| Mar 26, 2020 | Medtronic MiniMed MiniMed Paradigm Model 511 Insulin Pump Open, Classified |
LZG | K041318 |
| Mar 26, 2020 | Medtronic MiniMed MiniMed Insulin Pump, model # MMT-508 Open, Classified |
LZG | K990801 |
| Feb 13, 2020 | Insulet 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 |
LZG | K192659 |
| Nov 4, 2019 | Medtronic 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 |
LZG | K001829 K120206 |
| Nov 4, 2019 | Medtronic 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 |
LZG | K990801 |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 30 U/D, Part Number 2568-02 Terminated |
LZG | K103825 |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 20 U/D, Part Number 2568-03 Terminated |
LZG | K103825 |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 40 U/D, Part Number 2260-01 Terminated |
LZG | K103825 |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 30 U/D, Part Number 2260-02 Terminated |
LZG | K103825 |
| Jul 3, 2019 | Valeritas, Incorporated DEMO No Needle Corrugated Carton 20 U/D, Part Number 2260-03 Terminated |
LZG | K103825 |
| Dec 18, 2018 | Insulet Corporation Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 Terminated |
LZG | K180045 |
| Dec 15, 2015 | Insulet 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 |
LZG | K122953 |
| Dec 15, 2015 | Insulet 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 |
LZG | K122953 |
| Sep 10, 2015 | Elcam 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 |
LZG | K122953 |
| Sep 10, 2015 | Elcam 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 |
LZG | K122953 |
| Sep 4, 2015 | Insulet 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 |
LZG | K122953 |
| Sep 4, 2015 | Insulet 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 |
LZG | K122953 |
| Jun 9, 2015 | Roche Diabetes Care, Inc. AccuChek Spirit insulin infusion pump. Terminated |
LZG | K042887 |
| Jun 9, 2015 | Roche Diabetes Care, Inc. AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System. Terminated |
LZG | K111353 |
| Mar 2, 2015 | Medtronic 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 |
LZG | None listed |
| Oct 29, 2014 | Roche 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 |
LZG | K111353 |
| Oct 24, 2014 | Animas 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 |
LZG | None listed |
| Feb 10, 2014 | Tandem Diabetes Care Inc T:slim Insulin Delivery System
Insulin Infusion Pump Terminated |
LZG | K111210 |
| Nov 5, 2013 | Insulet 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 |
LZG | K122953 |
| Nov 5, 2013 | Insulet 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 |
LZG | K122953 |
| Apr 3, 2013 | Animas 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 |
LZG | K042873 |
| Feb 17, 2013 | Animas 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 |
LZG | K032257 K042873 |
| Oct 2, 2012 | Animas 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 |
LZG | K032257 |
| Apr 6, 2012 | Animas Corporation OneTouch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy. Terminated |
LZG | K080639 |
| Aug 12, 2011 | Animas Corporation Animas 2020 Insulin Infusion Pump.
Animas Corp.
An insulin infusion. Terminated |
LZG | None listed |
| May 10, 2011 | Animas Corporation 2.0 mL Cartridge/Syringe Piston component of Insulin Pump
Insulin infusion Terminated |
LZG | K032257 |
| Sep 10, 2010 | Animas Corporation Animas IR 1250 (1200 plus)
Intended use:deliver insulin therapy Terminated |
LZG | None listed |
| Sep 10, 2010 | Animas Corporation Animas IR 1200
Intended use:deliver insulin therapy Terminated |
LZG | K032257 |
| Sep 10, 2010 | Animas Corporation Animas 2020 Insulin Infusion Pumps
Intended use:deliver insulin therapy Terminated |
LZG | None listed |
| Sep 10, 2010 | Animas Corporation One Touch Ping Glucose Management Systems
Intended use: deliver insulin therapy Terminated |
LZG | K080639 |
| May 8, 2010 | Animas Corporation One Touch Ping Insulin Pump using ezManager Max diabetes management software Terminated |
LZG | K080639 |
| May 26, 2009 | Disetronic Medical Systems, Inc. Roche ACCU-CHEK Spirit insulin pump. Part numbers 4540492001, 4759702001 and 4759729001. Terminated |
LZG | K060876 |
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