Cleared Traditional

Moda-flx Hemodialysis System and Cartridge (K233798) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233798 · Diality, Inc. · Gastroenterology & Urology device
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Aug 2024
Decision
247d
Days
Class 2
Risk

K233798 is an FDA 510(k) clearance for the Moda-flx Hemodialysis System and Cartridge. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Diality, Inc. (Irvine, US). The FDA issued a Cleared decision on August 2, 2024 after a review of 247 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 Diality, Inc. devices

Submission Details

510(k) Number K233798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2023
Decision Date August 02, 2024
Days to Decision 247 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
117d slower than avg
Panel avg: 130d · This submission: 247d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K233798.
DHF 0.2 Hemoconcentrator (DHF 02)
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FX CorAL 40 (F00009214)
K242053 · Fresenius Medical Care Renal Therapies Group, LLC · Mar 2025
FX CorAL 60 (F00012969)
K243874 · Fresenius Medical Care Renal Therapies Group, LLC · Feb 2025
HemoCare Hemodialysis System
K233557 · Deka Research and Development · Jul 2024
multiFlux 1000 (F00012408)
K240394 · Fresenius Medical Care Renal Therapies Group, LLC · May 2024
Tablo® Hemodialysis System
K232776 · Outset Medical, Inc. · May 2024