# K031199: Enteralite Infinity Enteral Feeding Pump

- Pathway: 510(k) (Traditional)
- Applicant: Zevex Intl., Inc.
- Decided: Jul 9, 2003 after 86 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851539 (1985). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954735: Enteralite, Zevex Intl., Inc. (1996) Summary page 1.

## Most influential descendants
- K232205: Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed Set (2023), 0 descendants of its own
- K131154: Enteralite Infinity Spike Enteral Delivery Set; Enteralite Infinity 500 ML Bag Enteral Delivery Set; (2014), 0 descendants of its own

## Recalls of this device
- Nov 8, 2012 · Class II · Z-0294-2013: MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the
- Oct 12, 2012 · Class II · Z-0764-2013: The firm is adding an addendum to the operator's manual for Infinity Enteralite Ambulatory Feeding Pumps pertaining to the Infinite Dose mode and the inability of the Pump to detect air in line.
- Dec 18, 2008 · Not classified · Z-2112-2009: Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.
- Dec 18, 2008 · Not classified · Z-2113-2009: Enteral feeding pumps may not accurately deliver fluid, potentially under-infusing or over-infusing.

## Indications for use
The EnteraLiteO InfinityTMEnteral 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/K031199
Methodology: https://510kreport.com/methodology