# K142539: EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set

- Pathway: 510(k) (Traditional)
- Applicant: Zevex, Inc.
- Decided: Jan 8, 2015 after 121 days
- Product code: PIF (Gastrointestinal Tubes With Enteral Specific Connectors)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K851539 (1985). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012147: Device Modification of Enteral Feeding Sets for Gravity and Pump Use, Zevex, Inc. (2001) Summary page 4.

## Most influential descendants
- K240052: Disposable Enteral Feeding Sets (2024), 0 descendants of its own
- K210854: Enteral Feeding Set (2021), 0 descendants of its own

## Recalls of this device
- Nov 20, 2015 · Class II · Z-0415-2016: Potential for leaking between the purple ENFit connector and the white transitional stepped connector due to cracking or breaking of the purple connector.

## Indications for use
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a preprogrammed pump or user controlled rate. These enteral feeding sets interface with the patient’s feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a bag to contain the feeding solution and/or a spike to connect to a prefilled container.

Source page: https://510kreport.com/device/K142539
Methodology: https://510kreport.com/methodology