# K082863: Dynarex Enteral Delivery Pump Set with Spike (1000ML), Dynarex Enteral Feeding Sets for Gravity and Pump Use (1000ML)

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corporation
- Decided: Jan 9, 2009 after 102 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: 3 generations back to K851539 (1985). 5 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 16 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 1.

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

## Indications for use
The devices in this product family are used 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 devices may include a bag to contain the feeding solution and/or a spike, to connect to a pre-filled container. These devices are food contacting.

Source page: https://510kreport.com/device/K082863
Methodology: https://510kreport.com/methodology