K140439 is an FDA 510(k) clearance for the OMNIPOD INSULIN MANAGEMENT SYSTEM. This device is classified as a Pump, Infusion, Insulin (Class II - Special Controls, product code LZG).
Submitted by Insulet Corporation (Bedford, US). The FDA issued a Cleared decision on November 13, 2014, 265 days after receiving the submission on February 21, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K140439 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 21, 2014 |
| Decision Date | November 13, 2014 |
| Days to Decision | 265 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 |