# K231826: Omnipod 5 ACE Pump

- Pathway: 510(k) (Traditional)
- Applicant: Insulet Corporation
- Decided: Oct 18, 2023 after 119 days
- Product code: QFG (Alternate Controller Enabled Insulin Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 880.5730
- Recalls of this device: 5 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN180058 (2019). 3 ancestors in all.
1 later device descends 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)
- K203768: Omnipod 5 ACE Pump (Pod), Insulet Corporation (2022) Summary page 4.

## Most influential descendants
- K260001: Mint ACE Pump (2026), 0 descendants of its own

## Recalls of this device
- May 20, 2026 · Class I · Z-2603-2026: 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 
- Mar 12, 2026 · Class I · Z-1797-2026: Due to a manufacturing defect, certain Omnipod 5 Pods from 49 lots have an internal soft cannula tear that results in insulin leaking into the Pod instead of being delivered to the user regardless of 
- Sep 11, 2025 · Class II · Z-0132-2026: The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneous
- May 23, 2025 · Class II · Z-2016-2025: Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a comma is not recognized as a decimal separator and the user cannot enter a decimal separator in any manual
- Nov 30, 2023 · Class I · Z-0591-2024: The bolus calculator is not recording the decimal point if it is the first value entered when changing a bolus dose. This may lead to an over-delivery of insulin to the user if the user does not recog

## 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/K231826
Methodology: https://510kreport.com/methodology