# K954735: Enteralite

- Pathway: 510(k) (Traditional)
- Applicant: Zevex Intl., Inc.
- Decided: Apr 15, 1996 after 182 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K851539 (1985). 2 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913413: Kangaroo (R) Pet (TM) Enteral Feed Pump/Charger Base, Sherwood Medical Co. (1991) Summary page 1.
- K851539: Chesebrough-Ponds Kangaroo Pump Set W/Easy-Cap Clo, Chesebrough-Pond'S U.S.A. Co. (1985) Summary page 1.

## Most influential descendants
- K012147: Device Modification of Enteral Feeding Sets for Gravity and Pump Use (2001), 14 descendants of its own
- K082863: Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML) (2009), 10 descendants of its own
- K133077: Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag Set (2014), 8 descendants of its own
- K150286: Medline Enteral Feeding Sets (2015), 7 descendants of its own
- K163586: Trovita Health Science Safe-T Feed Ready-to-Feed Pouch with ENFit Connector (2017), 2 descendants of its own

## Indications for use
The EnteraLite enteral feeding pump with disposable set is a small, lightweight pump used to dispense liquid nutrients at a user controlled rate to patients. The device may be used in the hospital or at home by bed-ridden or ambulatory patients. The device is also designed for use with pediatric patients.

Source page: https://510kreport.com/device/K954735
Methodology: https://510kreport.com/methodology