Omnipod 6 algorithm
FDA 510(k) clearance K261461 · decided 2026-06-29
Clearance details
- K-number
- K261461
- Device name
- Omnipod 6 algorithm
- Applicant
- Insulet Corporation
- Decision
- Substantially Equivalent
- Date received
- 2026-05-04
- Decision date
- 2026-06-29
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- QJI
- Device class
- 2
- Regulation number
- 862.1356
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.