Kangaroo OMNI Enteral Feeding Pump (385400 ) +9 more— 510(k) K221603

Clearance details

Device name as filed

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

Applicant

Cardinal Health, LLC

Product code

Code LZH

Device class

Class 2

Regulation

21 CFR 880.5725

Advisory panel

General Hospital

Date received

2022-06-02

Decision date

2022-12-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Waukegan, IL, US

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Death

12

Malfunction

4,186

Total

4,198

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →