The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod 5 Smartbolus Calculator.
| Device ID | K203772 |
| 510k Number | K203772 |
| Device Name: | Omnipod 5 SmartBolus Calculator |
| Classification | Continuous Glucose Monitor Informed Insulin Dose Calculator |
| Applicant | Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Contact | Julie Perkins |
| Correspondent | Julie Perkins Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Product Code | QRX |
| CFR Regulation Number | 862.1358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2022-01-27 |