Omnipod 6 algorithm— 510(k) K261461
Substantially EquivalentInsulet Corporation
FDA 510(k) clearance K261461 for Omnipod 6 algorithm, Substantially Equivalent on 2026-06-29. Applicant: Insulet Corporation. Device class: 2.
Summary
Insulet's Omnipod 6 algorithm is filed under QJI, interoperable automated glycemic controllers. The record doesn't describe the algorithm beyond its name and the code name.
Class II, 21 CFR 862.1356. Clinical Chemistry is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Insulet filed from Acton, Massachusetts. Review took 56 calendar days (May 4 to June 29, 2026).
Clearance details
- Applicant
- Insulet Corporation
- Product code
- Product code QJI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1356
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Acton, MA, US
Recent devices under product code QJI
view allMore clearances from Insulet Corporation
view allAdverse events under product code QJI
product code QJI- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.