K221603 is an FDA 510(k) clearance for the Kangaroo OMNI™ Enteral Feeding Pump (385400 ). This device is classified as a Pump, Infusion, Enteral (Class II - Special Controls, product code LZH).
Submitted by Cardinal Health, LLC (Waukegan, US). The FDA issued a Cleared decision on December 20, 2022, 201 days after receiving the submission on June 2, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725.
| 510(k) Number | K221603 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2022 |
| Decision Date | December 20, 2022 |
| Days to Decision | 201 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LZH - Pump, Infusion, Enteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |