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Insulet Corporation FDA Approvals
0 new drug approvals and 13 device clearances on file. Matched by name to PODD.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Omnipod 6 algorithm510(k)Jun 29, 2026Clinical Chemistry |
| Omnipod 5 algorithm510(k)Dec 3, 2025Clinical Chemistry |
| SmartAdjust Technology510(k)Aug 26, 2024Clinical Chemistry |
| SmartAdjust(TM) technology510(k)May 29, 2024Clinical Chemistry |
| SmartBolus Calculator510(k)Oct 18, 2023Clinical Chemistry |
| Omnipod 5 ACE Pump510(k)Oct 18, 2023Clinical Chemistry |
| Omnipod GO Insulin Delivery Device510(k)Apr 24, 2023General Hospital |
| SmartAdjust(TM) technology510(k)Aug 19, 2022Clinical Chemistry |
| SmartBolus Calculator510(k)Aug 19, 2022Clinical Chemistry |
| Omnipod 5 SmartBolus Calculator510(k)Jan 27, 2022Clinical Chemistry |
| Omnipod 5 ACE Pump (Pod)510(k)Jan 27, 2022Clinical Chemistry |
| SmartAdjust technology510(k)Jan 27, 2022Clinical Chemistry |
| Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System510(k)Aug 13, 2021General Hospital |