# K180045: Omnipod DASH Insulin Management System

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Jun 1, 2018 after 144 days
- Product code: LZG (Pump, Infusion, Insulin)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K042792 (2005). 4 ancestors in all.
3 later devices descend 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)
- K162296: OmniPod Insulin Management System, Insulet Corporation (2017) Summary page 4.

## Most influential descendants
- 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
- Dec 18, 2018 · Class II · Z-0347-2020: There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

## 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.

Source page: https://510kreport.com/device/K180045
Methodology: https://510kreport.com/methodology