FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Omnipod 5 ACE Pump
K Number: K231826
·
Decision Oct 18, 2023
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
23
Review Days
119
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Basic Information
- Device Name
- Omnipod 5 ACE Pump
- K Number
- K231826
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5730
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Insulet Corporation
- Date Received
- June 21, 2023
- Decision Date
- October 18, 2023
- Product Code
- QFG
- 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 |
|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | FDA class 2 | Clinical Chemistry |
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Other Clearances by Insulet Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251779 | Omnipod 5 algorithm | Dec 3, 2025 | Substantially Equivalent |
| K241777 | SmartAdjust Technology | Aug 26, 2024 | Substantially Equivalent |
| K232741 | SmartAdjust(TM) technology | May 29, 2024 | 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 |