# K012147: Device Modification of Enteral Feeding Sets for Gravity and Pump Use

- Pathway: 510(k) (Special)
- Applicant: Zevex, Inc.
- Decided: Nov 2, 2001 after 115 days
- Product code: KNT (Tubes, Gastrointestinal (And Accessories))
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K851539 (1985). 4 ancestors in all.
14 later devices descend from it; 2 cite it directly.
0 of 19 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.
- K862489: Enteral Feeding Sets for Gravity and Pump Use, Knight Medical, Inc. (1986) Summary page 1.

## Most influential descendants
- 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
- K142539: EnteraLite Infinity Enteral Pump Delivery Set, 1200 mL Enteral Feeding Delivery Set (2015), 2 descendants of its own

## Indications for use
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a 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 pre-filled container.

Source page: https://510kreport.com/device/K012147
Methodology: https://510kreport.com/methodology