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
FDA 510(k) K221603 · Cardinal Health, LLC
510(k) numberK221603
Submission
- Device name
- 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
- Applicant
- Cardinal Health, LLC
Waukegan, IL, US - Received
- June 2, 2022
- Decision date
- December 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZH – Pump, Infusion, Enteral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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|---|---|---|---|
| K253558 | Luminoah FLOW Enteral Nutrition SystemLZH · Traditional | Luminoah | 04/20/2026SE |
| K232205 | Vesco Q Enteral Feeding Pump; Vesco Q 500mL Bag Feed Set; Vesco Q 1000mL Bag Feed…LZH · Traditional | Vesco Medical, LLC | 10/23/2023SE |
| K220230 | AMSure Enteral Feeding PumpLZH · Traditional | Amsino International, Inc. | 11/10/2022SE |
| K200051 | PUGGLE Enteral Feeding Pump and Feeding SetLZH · Traditional | Amsino International, Inc. | 09/25/2020SE |
| K153074 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo…LZH · Traditional | Covidien | 07/06/2016SE |
| K143263 | Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding SetsLZH · Traditional | Covidien | 05/29/2015SE |
| K141479 | Kangaroo Enteral Feeding Set with Enfit ConnectorsLZH · Traditional | Covidien | 12/23/2014SE |
| K131154 | Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral…LZH · Special | Zevex, Inc. | 02/12/2014SE |
| K111381 | Medi-Sis Syringe Infusion SystemLZH · Traditional | Acacia, Inc. | 01/13/2012SE |
| K060316 | Compat Go Enteral Feeding Pump and Administration SetsLZH · Traditional | Fresenius Kabi Deutschland GmbH | 06/23/2006SE |
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Questions and answers
When was 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 cleared by the FDA?
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 (K221603) received a 510(k) decision of Substantially Equivalent on December 20, 2022, 201 days after the submission was received.
What is the product code of K221603?
The FDA product code is LZH – Pump, Infusion, Enteral, a Class II (moderate risk) device regulated under 21 CFR 880.5725.