Cleared Traditional

K253558 - Luminoah FLOW™ Enteral Nutrition System

K253558 is an FDA 510(k) clearance for Luminoah FLOW Enteral Nutrition System, manufactured by Luminoah. The device is a Class 2 General Hospital device with product code LZH cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K253558 · Luminoah · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2026
Decision
154d
Days
Class 2
Risk

K253558 is an FDA 510(k) clearance for the Luminoah FLOW™ Enteral Nutrition System. Classified as Pump, Infusion, Enteral (product code LZH), Class II - Special Controls.

Submitted by Luminoah (Charlottesville, US). The FDA issued a Cleared decision on April 20, 2026 after a review of 154 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Luminoah devices

FDA 510(k) Submission Details - K253558

510(k) Number K253558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2025
Decision Date April 20, 2026
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZH Device Classification - Class 2, Special Controls

Product Code LZH Pump, Infusion, Enteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LZH Pump, Infusion, Enteral

All 19
Devices cleared under the same product code (LZH) and FDA review panel - the closest regulatory comparables to K253558.
Vesco Q™ Enteral Feeding Pump
K232205 · Vesco Medical, LLC · Oct 2023
Kangaroo OMNI™ Enteral Feeding Pump (385400 )
K221603 · Cardinal Health, LLC · Dec 2022
AMSure Enteral Feeding Pump
K220230 · Amsino International, Inc. · Nov 2022
PUGGLE Enteral Feeding Pump and Feeding Set
K200051 · Amsino International, Inc. · Sep 2020
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal
K153074 · Covidien · Jul 2016
Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets
K143263 · Covidien · May 2015