K192659 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 October 21, 2019, 26 days after receiving the submission on September 25, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K192659 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2019 |
| Decision Date | October 21, 2019 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZG — Pump, Infusion, Insulin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |