# K191679: Omnipod DASH Insulin Management System with interoperable technology

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Sep 20, 2019 after 88 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN180058 (2019). 1 ancestor in all.
6 later devices descend from it; 4 cite it directly.
1 of 8 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN180058: t:slim X2 insulin pump with interoperable technology, Tandem Diabetes Care, Inc. (2019) Summary page 4.

## Most influential descendants
- K203768: Omnipod 5 ACE Pump (Pod) (2022), 2 descendants of its own
- K231826: Omnipod 5 ACE Pump (2023), 1 descendant of its own
- K260001: Mint ACE Pump (2026), 0 descendants of its own
- K234027: embecta Insulin Delivery System (2024), 0 descendants of its own
- K230545: Inessa System (2023), 0 descendants of its own

## Indications for use
The Omnipod DASH Insulin Management System (the Pump) with interoperable technology is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. The Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute and confirm commands from these devices. The Pump is intended for single patient, home use and requires a prescription. The Pump is indicated for use with NovoLog, Humalog, Admelog, or Apidra U-100 insulin.

Source page: https://510kreport.com/device/K191679
Methodology: https://510kreport.com/methodology