# K133077: Generica Medical Enternal Delivery; Pump Bag Set, Pump Spike Set, Gravity Bag Set

- Pathway: 510(k) (Traditional)
- Applicant: Generica Medical International, Inc.
- Decided: Jul 28, 2014 after 301 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: 4 generations back to K851539 (1985). 6 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082863: Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML), Dynarex Corporation (2009) Summary page 1.

## Most influential descendants
- 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
- K222678: Mobility+ Enteral Feeding System (2022), 1 descendant of its own
- K210971: EnteraLoc Flow (2021), 1 descendant of its own
- K181276: CONOD Enteral Feeding Sets (2018), 1 descendant of its own

## Indications for use
The Enteral Feeding Sets are intended to dispense liquid nutrients (feeding solutions) at a user controlled rate. These enteral feeding sets interface with the patients feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The enteral feeding sets may include a bag to contain the feeding solution and/or spike to connect to a pre-filled container.

Source page: https://510kreport.com/device/K133077
Methodology: https://510kreport.com/methodology