510(k) · Cleared
Recalled · Class II · 2023Omnipod 5 ACE Pump (Pod)
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 Jan 27, 2022 as substantially equivalent to K191679 (Insulet Corporation, 2019) after a 400-day review. Its family tree reaches back 2 generations to 2019. 1 of the 5 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 27, 2022
- Review
- 400 days
- Class
- Class II
- Product code
- QFG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN180058 (2019). 2 later devices descend from it, 1 citing it directly. 1 of the 5 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- 1 generation backK191679 Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation · 2019
- This deviceK203768 Omnipod 5 ACE Pump (Pod)Insulet Corporation · 2022
- Descendant · cites it directly · 1 of its ownK231826 Omnipod 5 ACE PumpInsulet Corporation · 2023 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK260001 Mint ACE PumpBeta Bionics, Inc. · 2026
Class I recalls in this family
- K231826 Omnipod 5 ACE Pumpcites it directly · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| −1 | K191679 | Omnipod DASH Insulin Management System with interoperable technology | Insulet Corporation | 2019 | — |
| 0 (this device) | K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022 | — |
| +1 | K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023 | Class I |
| +2 | K260001 | Mint ACE Pump | Beta Bionics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 1 |
| 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 |
|---|---|---|---|
| * | K191679 | Omnipod DASH Insulin Management System with interoperable technologySummary page 4…21 CFR 880.5730 Submission Type: Traditional 510(k) Device Class: Class II K191679, Omnipod DASH Insulin Device Predicate: Management System with Interoperable… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231826 | Omnipod 5 ACE Pump Class I | 2023 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2023 | Class II | Z-2618-2023 | Software Design Change | 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 Omnipod 5 App which may cause a delay in… |
| Nov 14, 2022 | Class II | Z-0423-2023 | Device Design | 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 resistance in the Controller port. The… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K231826Omnipod 5 ACE PumpInsulet Corporation · 2023 · Cites it directly · ◆ in the 2023 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K231826 (Insulet Corporation, 2023) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K191679.
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. 2022, 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/K203768 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203768: Omnipod 5 ACE Pump (Pod).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203768
Report an extraction error
Are you the manufacturer?
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