510(k) · Cleared
ClearedOmnipod DASH Insulin Management System with interoperable technology
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 Sep 20, 2019 as substantially equivalent to DEN180058 (Tandem Diabetes Care, Inc., 2019) after an 88-day review. Its family tree reaches back 1 generation to 2019. 1 of the 8 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Sep 20, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- QFG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN180058 (2019). 6 later devices descend from it, 4 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backDEN180058 t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. · 2019
- This deviceK191679 Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation · 2019
- Descendant · cites it directly · 2 of its ownK203768 Omnipod 5 ACE Pump (Pod)Insulet Corporation · 2022 · Recalled
- Descendant · 2 generations on · 1 of its ownK231826 Omnipod 5 ACE PumpInsulet Corporation · 2023 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK260001 Mint ACE PumpBeta Bionics, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK234027 embecta Insulin Delivery SystemEmbecta Medical I, LLC · 2024
- Descendant · cites it directly · 0 of its ownK230545 Inessa SystemTriple Jump Israel, Ltd. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K231826 Omnipod 5 ACE Pump2 generations on · 2023
Most influential descendants
Showing 5 of 6 · See all- K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation · 2022 · cites it directly2descendants
- K231826Omnipod 5 ACE PumpInsulet Corporation · 2023 · 2 generations on1descendant
- K260001Mint ACE PumpBeta Bionics, Inc. · 2026 · 3 generations on0descendants
- K234027embecta Insulin Delivery SystemEmbecta Medical I, LLC · 2024 · cites it directly0descendants
- K230545Inessa SystemTriple Jump Israel, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN180058 | t:slim X2 insulin pump with interoperable technology | Tandem Diabetes Care, Inc. | 2019 | — |
| 0 (this device) | K191679 | Omnipod DASH Insulin Management System with interoperable technology | Insulet Corporation | 2019 | — |
| +1 | K203768 | Omnipod 5 ACE Pump (Pod) | Insulet Corporation | 2022 | 2 |
| +2 | K231826 | Omnipod 5 ACE Pump | Insulet Corporation | 2023 | Class I |
| +3 | K260001 | Mint ACE Pump | Beta Bionics, Inc. | 2026 | — |
| +1 | K234027 | embecta Insulin Delivery System | Embecta Medical I, LLC | 2024 | — |
| +1 | K230545 | Inessa System | Triple Jump Israel, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 3 | 1 |
| 2024 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | DEN180058 | t:slim X2 insulin pump with interoperable technologySummary page 4…Model Number (Pod): BLE-I1-529 Model Number (PDM): USA1-D001-MG-USA1 DEN180058, t:slim X2 insulin pump with Device Predicate: interoperable technology I… | 2019 |
| † | K182630 | Omnipod Insulin Management System, Omnipod DASH Insulin Management System | 2019 |
| † | K180045 | Omnipod DASH Insulin Management System | 2018 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 2 generations on · ◆ in the 2023 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
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. 2019, 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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191679 · printed Nov 5, 2026
Cite this page
510(k) Report. “K191679: Omnipod DASH Insulin Management System with interoperable technology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K191679
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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