# K122953: Omnipod Insulin Managment System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Dec 7, 2012 after 73 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 8 (4 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K042792 (2005). 2 ancestors in all.
8 later devices descend from it; 4 cite it directly.
2 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111669: Freestyle Glucose Meter Incorporated Into the Omnipod Insulin Management Systems, Insulet Corporation (2011) Summary page 1.
- K042792: Ixl-II Diabetes Management System, Insulet Corporation (2005) Summary page 1.

## Most influential descendants
- K162296: OmniPod Insulin Management System (2017), 4 descendants of its own
- K180045: Omnipod DASH Insulin Management System (2018), 3 descendants of its own
- K182630: Omnipod Insulin Management System, Omnipod DASH Insulin Management System (2019), 2 descendants of its own
- K192659: Omnipod Insulin Management System, Omnipod DASH Insulin Management System (2019), 1 descendant of its own
- K211575: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (2021), 0 descendants of its own

## Recalls of this device
- Nov 2, 2015 · Class I · Z-0393-2016: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
- Nov 2, 2015 · Class I · Z-0394-2016: Pod's needle mechanism fails to deploy or there is a delay in the deployment of the needle mechanism.
- Jul 19, 2015 · Class II · Z-2749-2015: Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
- Jul 19, 2015 · Class II · Z-2748-2015: Punctured blister packages were detected during the packaging process at the manufacturing site. Potential for device contamination.
- Jul 13, 2015 · Class I · Z-2485-2015: OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
- Jul 13, 2015 · Class I · Z-2484-2015: OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing insulin to be pumped or the audible alarm is displayed on the PDM and pod will not deliver insulin
- Sep 27, 2013 · Class II · Z-0166-2014: Alcohol Prep Pads contained within the kit are not properly labeled.
- Sep 27, 2013 · Class II · Z-0165-2014: Alcohol Prep Pads contained within the kit are not properly labeled.

## Indications for use
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 POM glucose meter is intended far 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.

Source page: https://510kreport.com/device/K122953
Methodology: https://510kreport.com/methodology