# K211575: Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Aug 13, 2021 after 84 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K042792 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192659: Omnipod Insulin Management System, Omnipod DASH Insulin Management System, Insulet Corporation (2019) Summary page 5.

## Recalls of this device
- May 20, 2026 · Class I · Z-2604-2026: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode 
- May 20, 2026 · Class I · Z-2605-2026: External soft cannula damage during manufacturing that results in insulin leaking around the Pod instead of being delivered to the user regardless of basal or bolus delivery. The primary failure mode 
- Oct 17, 2022 · Class I · Z-0154-2023: The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint al

## 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 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. 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.

Source page: https://510kreport.com/device/K211575
Methodology: https://510kreport.com/methodology