510(k) · Cleared
ClearedOmnipod 6 algorithm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insulet Corporation · QJI Interoperable Automated Glycemic Controller
Cleared on Jun 29, 2026 as substantially equivalent to K251779 (Insulet Corporation, 2025) after a 56-day review. Its family tree reaches back 4 generations to 2022.
- Decided
- Jun 29, 2026
- Review
- 56 days
- Class
- Class II
- Product code
- QJI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K220394 (2022). No later device cites it as a predicate yet.
- Root · 4 generations backK220394 SmartAdjust (TM) technologyInsulet Corporation · 2022
- 3 generations backK232741 SmartAdjust (TM) technologyInsulet Corporation · 2024
- 2 generations backK241777 SmartAdjust™ TechnologyInsulet Corporation · 2024
- 1 generation backK251779 Omnipod 5 algorithmInsulet Corporation · 2025
- This deviceK261461 Omnipod 6 algorithmInsulet Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K220394 | SmartAdjust (TM) technology | Insulet Corporation | 2022 | — |
| −3 | K232741 | SmartAdjust (TM) technology | Insulet Corporation | 2024 | — |
| −2 | K241777 | SmartAdjust™ Technology | Insulet Corporation | 2024 | — |
| −1 | K251779 | Omnipod 5 algorithm | Insulet Corporation | 2025 | — |
| 0 (this device) | K261461 | Omnipod 6 algorithm | Insulet Corporation | 2026 | — |
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.
Planning a device in QJI? 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 QJI device
- #1 K253701 SmartGuard Technology; Predictive Low Glucose…score 17.1 · 12 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 |
|---|---|---|---|
| * | K251779 | Omnipod 5 algorithmSummary page 5…umbers 21 CFR 862.1356 Submission Type Traditional 510(k) Device Class Class II Predicate Device K251779, Omnipod 5 algorithm Insulet Corporation Traditional 510(k) Omnipod 6 algorithm (iAGC)… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 1.3 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All QJI devicesQJI Interoperable Automated Glycemic Controller: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QJI
8so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJI
130in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJI
No recall names QJI since 2007.
Adverse event reports per year · QJI
3in 2025
MAUDE reports naming product code QJI, 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 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 4 | 251 | 0 | 26 |
| 2024 | 4 | 174 | 0 | 15 |
| 2025 | 5 | 130 | 0 | 3 |
| 2026 | 8 | 65 | 0 | — |
What is it indicated for?
The Omnipod 6 algorithm is intended for use with compatible integrated continuous glucose monitors (ICGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. The Omnipod 6 algorithm is intended for the management of type 1 diabetes mellitus in persons 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. The Omnipod 6 algorithm is intended for single patient use and requires a prescription.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261461: Omnipod 6 algorithm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261461
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026