# K100700: Med-RX Pediatric Feeding Tubes and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Benlan, Inc.
- Decided: Dec 13, 2010 after 276 days
- Product code: FPD (Tube, Feeding)
- Device class: 2
- Regulation: 21 CFR 876.5980
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K810156 (1981). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060944: Nutrisafe 2, Vygon Corp. (2006) Summary page 2.
- K082710: Safechild Enteral Feeding Tube and Accessories and Feeding Tube Extension Set, Neochild, LLC (2009) Summary page 1.

## Recalls of this device
- Jul 22, 2019 · Class II · Z-2293-2019: Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube.
- Jul 16, 2019 · Class II · Z-2281-2019: The firm received a complaint that the connector detached from the feeding tube.
- Dec 17, 2018 · Class II · Z-0746-2019: Enteral Safe Feeding Tubes labeled as 6.5 FR X 24" contained 5 FR X 24" Enteral Safe Feeding Tubes.
- Dec 1, 2018 · Class II · Z-0725-2019: The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
- Jun 11, 2018 · Class II · Z-2440-2018: The product may be packaged with the incorrect length of feeding tube as labeled.
- Dec 11, 2015 · Class II · Z-0595-2016: The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size.

## Indications for use
The MED-RX Pediatric Feeding Tube and Accessories are disposable, single use enteral feeding devices featuring non-luer enteral only connectors. The MED-RX Pediatric Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding, as directed by a physician. The MED-RX Enteral Extension Set is an accessory to the MED-RX Pediatric Feeding Tube, to be used to deliver fluids from the nutritional source to an existing non-luer pediatric feeding tube. The MED-RX Pediatric Feeding Tube and Accessories are for hospital use, pediatric patient use only, and are not intended for use beyond 30 days.

Source page: https://510kreport.com/device/K100700
Methodology: https://510kreport.com/methodology