# K192659: Omnipod Insulin Management System, Omnipod DASH Insulin Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Oct 21, 2019 after 26 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K042792 (2005). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182630: Omnipod Insulin Management System, Omnipod DASH Insulin Management System, Insulet Corporation (2019) Summary page 5.

## Most influential descendants
- K211575: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (2021), 0 descendants of its own

## Recalls of this device
- Feb 1, 2021 · Class II · Z-1203-2021: Certain foreign user guides include a misprint which could lead to an incorrect bolus delivery and hypoglycemia. Only Outside the US (OUS): Error in the Omnipod DASH User Guide text, page 6 of the Use
- Apr 2, 2020 · Class II · Z-2165-2020: After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a b
- Apr 2, 2020 · Class II · Z-2164-2020: After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a b
- Feb 13, 2020 · Class II · Z-1553-2020: In certain scenarios, the Omnipod DASH PDM may suggest an inaccurate bolus amount based on a blood glucose value that is more than 10 minutes old when the user does not exit the bolus calculator as de

## Indications for use
The Omnipod DASH 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. Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements. 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.

Source page: https://510kreport.com/device/K192659
Methodology: https://510kreport.com/methodology