Cleared Traditional

K261399 - ELISIO-HX

K261399 is the FDA 510(k) clearance for ELISIO-HX by Nipro Medical Corporation. It is a Class 2 Gastroenterology & Urology device (product code QAX) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K261399 · Nipro Medical Corporation · Gastroenterology & Urology device
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Jul 2026
Decision
90d
Days
Class 2
Risk

K261399 is an FDA 510(k) clearance for the ELISIO™-HX. Classified as Hemodialyzer With Expanded Solute Removal Profile (product code QAX), Class II - Special Controls.

Submitted by Nipro Medical Corporation (Miami, US). The FDA issued a Cleared decision on July 28, 2026 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5862 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nipro Medical Corporation devices

Submission Details

510(k) Number K261399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2026
Decision Date July 28, 2026
Days to Decision 90 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 130d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QAX Hemodialyzer With Expanded Solute Removal Profile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5862
Definition A Hemodialyzer With Expanded Solute Removal Profile Is Intended For Use As Part Of An Artificial Kidney System For The Treatment Of Patients With Renal Failure By Performing Such Therapies As Hemodialysis, Hemofiltration, And Hemodiafiltration. A Hemodialyzer With Expanded Solute Removal Profile Includes Modifications To The Semipermeable Membrane That Allows For Increased Removal Of Uremic Retention Solutes Compared With Standard High-flux Hemodialyzers Of The High Permeability Hemodialysis System Classification (21 Cfr §876.5860), Including Solutes At The Upper End Of The “middle” Molecular Weight Range (0.5 Kda To 60 Kda).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT07058909 Completed Interventional Industry-sponsored

Premarket Clinical Safety Assessment of the ELISIO™-HX

22
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Renal Failure; Acute Renal Failure; Chronic Renal Failure; Chronic Kidney Diseases; End Stage Renal Disease
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Kiranjit Dhillon, MD, MPH
Sponsor Nipro Medical Corporation (industry)
Started 2025-09-08 → Primary completion 2026-02-25
Primary outcome
Change in serum level of albumin
Secondary outcome
Change in Factor VII
Study completed - no results published. This trial concluded in 2026 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov