Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
FDA 510(k) K143263 · Covidien
510(k) numberK143263
Submission
- Device name
- Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
- Applicant
- Covidien
Mansfield, MA, US - Received
- November 13, 2014
- Decision date
- May 29, 2015
- 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
Other 510(k)s with product code LZH
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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 |
| K221603 | Kangaroo OMNI Enteral Feeding Pump (385400 );Kangaroo OMNI Feeding Set 500ml (B5FD…LZH · Traditional | Cardinal Health, LLC | 12/20/2022SE |
| 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 |
| 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 Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets cleared by the FDA?
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (K143263) received a 510(k) decision of Substantially Equivalent on May 29, 2015, 197 days after the submission was received.
What is the product code of K143263?
The FDA product code is LZH – Pump, Infusion, Enteral, a Class II (moderate risk) device regulated under 21 CFR 880.5725.