# K253558: Luminoah FLOW™ Enteral Nutrition System

- Pathway: 510(k) (Traditional)
- Applicant: Luminoah
- Decided: Apr 20, 2026 after 154 days
- Product code: LZH (Pump, Infusion, Enteral)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K011442 (2001). 29 ancestors in all.
No later device cites it as a predicate yet.
8 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal, Covidien (2016) Summary page 5.

## Indications for use
The Luminoah Flow TM Enteral Nutrition System is intended for the delivery of supplemental nutrition and fluids to the gastrointestinal system including nutritional formula, fluids, and/or water. The system is intended for use by healthcare professionals (HCP) to laypersons. The Luminoah Flow TM Enteral Nutrition System is indicated for use in individuals who are unable to obtain sufficient nutrition through eating and or swallowing. The system is indicated for use with the Luminoah FlowTM Administration Set and Luminoah branded accessories. The Luminoah FlowTM System can be used by an adult layperson, caretaker, or healthcare professional, for both adult and pediatric patients, ages 2 years and older. This system is not intended for use with neonates. The Luminoah FlowTMr Enteral Nutrition System is intended for hospital and acute care settings, as well as for home health use. It is intended to be used in both stationary and ambulatory conditions.

Source page: https://510kreport.com/device/K253558
Methodology: https://510kreport.com/methodology