Clearance Summary
Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD );Kangaroo OMNI ENtelliSet 500ml (E5FD );Kangaroo OMNI Feeding Set 1000ml (B10FD );Kangaroo OMNI ENtelliSet 1000ml (E10FD );Kangaroo OMNI ENPlus Spike Set (BSPFD );Kangaroo OMNI ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI received FDA 510(k) clearance under submission number K221603, sponsored by Cardinal Health, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2022-12-20.
- Submission: K221603
- Applicant / Sponsor: Cardinal Health, LLC
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2022-12-20
Classification & Regulation
This clearance is catalogued under FDA product code LZH and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.