# K020005: Infant Feeding Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Promedic, Inc.
- Decided: Jul 16, 2002 after 195 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 K810156 (1981). 4 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925854: Vygon - Enteral Feeding Tube - Polyurethane, Vygon Corp. (1994) Summary page 1.
- K861090: Nutri-Cath - Feeding Tube, Gesco Intl., Inc. (1986) Summary page 1.
- K971354: Knott NG Tube, Michael M. Knott, M.D. (1997) Summary page 1.

## Most influential descendants
- K052903: Pediatric Feeding Tube (2005), 6 descendants of its own
- K072756: Non-IV Adapter for Infant NG Tube (2007), 5 descendants of its own
- K082710: Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set (2009), 4 descendants of its own
- K092628: Enteral Feeding Tube and Accessories, Feeding Tube Extension Set (2010), 2 descendants of its own
- K162340: Stomach Tube (2017), 0 descendants of its own

## Indications for use
The Infant Feeding tube is intended to be placed into the stomach to permit the introduction of fluids as directed by the physician. Intended for nasogastric or orogastric placement. Limited to less than 30-day placement. Not intended for transpyloric placement.

Source page: https://510kreport.com/device/K020005
Methodology: https://510kreport.com/methodology