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Luminoah FLOW Enteral Nutrition System

by Luminoah

510(k) K253558

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253558 Date20 Apr 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LZH
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Luminoah Flow Enteral Nutrition System is a Pump, Infusion, Enteral device. It is designed for enteral nutrition delivery. The system is intended to provide nutrition to patients who rely on tube feeding.

The Luminoah Flow Enteral Nutrition System is supplied with a device class of 2 and is regulated under regulation number 880.5725. It has been cleared by the FDA under the traditional clearance type with the k number K253558. The device is used in a general hospital setting and is designed for portable enteral feeding solutions.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Luminoah Flow Enteral Nutrition System used for?

    The Luminoah Flow Enteral Nutrition System is used for enteral nutrition delivery, providing nutrition to patients who rely on tube feeding.

  • Is the Luminoah Flow Enteral Nutrition System cleared by the FDA?

    Yes, the Luminoah Flow Enteral Nutrition System has been cleared by the FDA under the traditional clearance type with the k number K253558.

  • In what setting is the Luminoah Flow Enteral Nutrition System typically used?

    The Luminoah Flow Enteral Nutrition System is designed for use in a general hospital setting, providing portable enteral feeding solutions.