# K040196: Kendall Epump Enteral Feeding Pump and Enteral Feeding Sets

- Pathway: 510(k) (Traditional)
- Applicant: Tyco Healthcare/Kendall
- Decided: May 5, 2004 after 97 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K945964 (1995). 1 ancestor in all.
8 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945964: Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets, Sherwood Medical Co. (1995) Summary page 1.

## Most influential descendants
- K143263: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets (2015), 4 descendants of its own
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (2016), 2 descendants of its own
- K253558: Luminoah FLOW™ Enteral Nutrition System (2026), 0 descendants of its own
- K221603: 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™ (2022), 0 descendants of its own
- K200051: PUGGLE Enteral Feeding Pump and Feeding Set (2020), 0 descendants of its own

## Recalls of this device
- Jan 19, 2021 · Class II · Z-1347-2021: The potential for air appearing in the enteral feed pumping set tubing during set-up.
- Dec 26, 2019 · Class II · Z-2103-2020: The feeding spike sets may leak at the interface of the tube and spike connector.
- Dec 26, 2019 · Class II · Z-2104-2020: The feeding spike sets may leak at the interface of the tube and spike connector.
- Dec 26, 2019 · Class II · Z-2100-2020: The feeding spike sets may leak at the interface of the tube and spike connector.
- Dec 26, 2019 · Class II · Z-2101-2020: The feeding spike sets may leak at the interface of the tube and spike connector.

## Indications for use
Intended for use in patients with any condition requiring enteral feeding and/or enteral hydration, which can be accomplished by means of an enteral feeding, pump and pump set. The pump and feeding sets are intended to be used in alternate, acute and home care settings by users ranging from laypersons to clinicians. The purpose of this device is to deliver enteral nutrition at a controlled rate to a patients gastrointestinal system.

Source page: https://510kreport.com/device/K040196
Methodology: https://510kreport.com/methodology