The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Omnipod 5 Ace Pump (pod).
| Device ID | K203768 |
| 510k Number | K203768 |
| Device Name: | Omnipod 5 ACE Pump (Pod) |
| Classification | Alternate Controller Enabled Insulin Infusion Pump |
| Applicant | Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Contact | Alexander Hamad |
| Correspondent | Alexander Hamad Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Product Code | QFG |
| CFR Regulation Number | 880.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-23 |
| Decision Date | 2022-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385083000213 | K203768 | 000 |
| 10385083000022 | K203768 | 000 |
| 10385081120302 | K203768 | 000 |