K211575 is an FDA 510(k) clearance for the Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Insulet Corporation (Acton, US). The FDA issued a Cleared decision on August 13, 2021, 84 days after receiving the submission on May 21, 2021.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K211575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2021 |
| Decision Date | August 13, 2021 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |