# K203768: Omnipod 5 ACE Pump (Pod)

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Jan 27, 2022 after 400 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN180058 (2019). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191679: Omnipod DASH Insulin Management System with interoperable technology, Insulet Corporation (2019) Summary page 4.

## Most influential descendants
- K231826: Omnipod 5 ACE Pump (2023), 1 descendant of its own
- K260001: Mint ACE Pump (2026), 0 descendants of its own

## Recalls of this device
- Feb 28, 2023 · Class II · Z-2618-2023: An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omni
- Nov 14, 2022 · Class II · Z-0423-2023: The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resi

## Indications for use
The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE 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 Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.

Source page: https://510kreport.com/device/K203768
Methodology: https://510kreport.com/methodology