510(k) · Cleared
Recalled · Class I · 2026Omnipod 5 ACE Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insulet Corporation · QFG Alternate Controller Enabled Insulin Infusion Pump
Cleared on Oct 18, 2023 as substantially equivalent to K203768 (Insulet Corporation, 2022) after a 119-day review. Its family tree reaches back 3 generations to 2019. 1 of the 5 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 5 times, including 3 Class I recalls.
- Decided
- Oct 18, 2023
- Review
- 119 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 5 (3 Class I)
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN180058 (2019). 1 later device descends from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 2 generations backK191679 Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation · 2019
- 1 generation backK203768 Omnipod 5 ACE Pump (Pod)Insulet Corporation · 2022 · Recalled
- This deviceK231826 Omnipod 5 ACE PumpInsulet Corporation · 2023
- Descendant · cites it directly · 0 of its ownK260001 Mint ACE PumpBeta Bionics, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260001Mint ACE PumpBeta Bionics, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −2 | K191679 | Omnipod DASH Insulin Management System with interoperable technology | Insulet Corporation | 2019 | — |
| −1 | K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022 | 2 |
| 0 (this device) | K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023 | — |
| +1 | K260001 | Mint ACE Pump | Beta Bionics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QFG device
- #1 K251032 MiniMed 780G insulin pumpscore 19.6 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203768 | Omnipod 5 ACE Pump (Pod)Summary page 4…s: 21 CFR 880.5730 Submission Type: Traditional 510(k) Device Class: Class II Device Predicate: K203768 (Omnipod 5 ACE Pump) Insulet Corporation Omnipod 5 ACE Pump (iOS) Traditional 510(k) 5.1 Purpose o… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260001 | Mint ACE Pump | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 20, 2026 | Class I | Z-2603-2026 | Process design | 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 is pump under-delivery due to loss of… |
| Mar 12, 2026 | Class I | Z-1797-2026 | Process design | 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 basal or bolus delivery. This defect… |
| Sep 11, 2025 | Class II | Z-0132-2026 | Software design | 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 simultaneously selecting a single number on the… |
| May 23, 2025 | Class II | Z-2016-2025 | Software design | 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 entry screen if the user manually… |
| Nov 30, 2023 | Class I | Z-0591-2024 | Software design | 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 recognize the error on the bolus calculator… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K260001 (Beta Bionics, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QFG devicesQFG Alternate Controller Enabled Insulin Infusion Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QFG
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QFG
44in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QFG
8so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · QFG
324,360in 2025
MAUDE reports naming product code QFG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 30,522 |
| 2021 | 0 | — | 0 | 74,701 |
| 2022 | 2 | — | 1 | 129,119 |
| 2023 | 9 | 150 | 1 (1) | 188,014 |
| 2024 | 5 | 89 | 0 | 273,180 |
| 2025 | 5 | 44 | 3 (1) | 324,360 |
| 2026 | 6 | 103 | 8 (1) | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231826: Omnipod 5 ACE Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231826
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026