FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Omnipod 5 algorithm
K Number: K251779
·
Decision Dec 3, 2025
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
19
Applicant Total
23
Review Days
176
Basic Information
- Device Name
- Omnipod 5 algorithm
- K Number
- K251779
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1356
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Insulet Corporation
- Date Received
- June 10, 2025
- Decision Date
- December 3, 2025
- Product Code
- QJI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QJI | Interoperable Automated Glycemic Controller | FDA class 2 | Clinical Chemistry |
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Other Clearances by Insulet Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K241777 | SmartAdjust Technology | Aug 26, 2024 | Substantially Equivalent |
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| K231826 | Omnipod 5 ACE Pump | Oct 18, 2023 | Substantially Equivalent |
| K231824 | SmartBolus Calculator | Oct 18, 2023 | Substantially Equivalent |
| K223372 | Omnipod GO Insulin Delivery Device | Apr 24, 2023 | Substantially Equivalent |
| K220394 | SmartAdjust(TM) technology | Aug 19, 2022 | Substantially Equivalent |
| K222239 | SmartBolus Calculator | Aug 19, 2022 | Substantially Equivalent |
| K203772 | Omnipod 5 SmartBolus Calculator | Jan 27, 2022 | Substantially Equivalent |
| K203768 | Omnipod 5 ACE Pump (Pod) | Jan 27, 2022 | Substantially Equivalent |
| K203774 | SmartAdjust technology | Jan 27, 2022 | Substantially Equivalent |