# K100526: Ameritus Entral (TM) Enteral Feeding Tube

- Pathway: 510(k) (Traditional)
- Applicant: Kentec Medical, Inc.
- Decided: Apr 22, 2010 after 57 days
- Product code: FPD (Tube, Feeding)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K945012 (1995). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082238: Neomed Polyurethane Feeding Tube, Neomed, Inc. (2008) Summary page 1.
- K072881: NEOMED Enteral FEEDING TUBE, Neomed, Inc. (2008) Summary page 1.

## Most influential descendants
- K180236: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) (2019), 1 descendant of its own
- K200082: BD Univia RightFit Enteral Extension Sets and Transitional Adapters (2020), 0 descendants of its own

## Recalls of this device
- Jan 17, 2020 · Class II · Z-2515-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jan 17, 2020 · Class II · Z-2520-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jan 17, 2020 · Class II · Z-2519-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jan 17, 2020 · Class II · Z-2518-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jan 17, 2020 · Class II · Z-2514-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jan 17, 2020 · Class II · Z-2516-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jan 17, 2020 · Class II · Z-2517-2020: Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube i
- Jun 23, 2017 · Class II · Z-3073-2017: Inadequate detectability of radiopaque stripes
- Jun 23, 2017 · Class II · Z-3074-2017: Inadequate detectability of radiopaque stripes

## Indications for use
The Amertius EntralI~ Feeding Tube is intended for nasogastric or orogastric delivery of various types of liquid nutritional media through the gastro intestinal tract of neonatal and small pediatric patients, and is not intended for use beyond 30 days.

Source page: https://510kreport.com/device/K100526
Methodology: https://510kreport.com/methodology