OMNIPOD INSULIN MANAGMENT SYSTEM— 510(k) K122953

Clearance details

Applicant

Insulet Corporation

Product code

Code LZG

Device class

Class 2

Regulation

21 CFR 880.5725

Advisory panel

General Hospital

Date received

2012-09-25

Decision date

2012-12-07

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bedford, MA, US

• K262153 — Pivot Insulin Delivery System2026-09-02
• K253534 — Pivot Insulin Delivery System2026-04-08
• K240158 — Modular Medical MODD1 Insulin Delivery System2024-09-04
• K241622 — Extended Reservoir; MiniMed Reservoir2024-07-02
• K223372 — Omnipod GO Insulin Delivery Device2023-04-24

• K261461 — Omnipod 6 algorithm2026-06-29
• K251779 — Omnipod 5 algorithm2025-12-03
• K241777 — SmartAdjust Technology2024-08-26
• K232741 — SmartAdjust(TM) technology2024-05-29
• K231824 — SmartBolus Calculator2023-10-18

Death

104

Injury

12,022

Malfunction

135,004

Other

1

Total

147,131

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0393-2016 — 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 the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.Class I·Terminated·Insulet Corporation·20151102
• Z-0394-2016 — 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 the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.Class I·Terminated·Insulet Corporation·20151102
• Z-2748-2015 — Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVLS) for pressure monitoring and intravenous fluid administration; Manufactured by: Elcam Medical ACAL, Israel. Sterile, Quantity 20.Class II·Terminated·Elcam Medical, Inc.·20150719
• Z-2749-2015 — 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., USA. SterileClass II·Terminated·Elcam Medical, Inc.·20150719
• Z-2484-2015 — 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 of diabetes mellitus in persons requiring insulin.Class I·Terminated·Insulet Corporation·20150713
• Z-2485-2015 — 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 diabetes mellitus in persons requiring insulin.Class I·Terminated·Insulet Corporation·20150713
• Z-0165-2014 — 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 Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.Class II·Terminated·Insulet Corporation·20130927
• Z-0166-2014 — 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 healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly.Class II·Terminated·Insulet Corporation·20130927

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122953.