# K131154: Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set;

- Pathway: 510(k) (Special)
- Applicant: Zevex, Inc.
- Decided: Feb 12, 2014 after 294 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: 3 generations back to K851539 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031199: Enteralite Infinity Enteral Feeding Pump, Zevex Intl., Inc. (2003) Summary page 1.

## Indications for use
The EnteraLite Infinity Enteral Feeding Pump is a rotary peristaltic pump designed to deliver programmed doses of enteral nutrition solutions at selectable rates.

Source page: https://510kreport.com/device/K131154
Methodology: https://510kreport.com/methodology