Cleared Special

K243607 - Moda-flx Hemodialysis System™ Cartridge (102121-001 ) (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K243607 · Diality, Inc. · Gastroenterology & Urology device
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Dec 2024
Decision
29d
Days
Class 2
Risk

K243607 is an FDA 510(k) clearance for the Moda-flx Hemodialysis System™ Cartridge (102121-001 ). Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Diality, Inc. (Irvine, US). The FDA issued a Cleared decision on December 20, 2024 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - the FDA gastroenterology and urology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diality, Inc. devices

Submission Details

510(k) Number K243607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2024
Decision Date December 20, 2024
Days to Decision 29 days
Submission Type Special
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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 75
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K243607.
VITAL Tubing Sets for Hemodialysis
K251341 · Vital Healthcare Sdn. Bhd. · Jan 2026
TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)
K251442 · Ningbo Tianyi Medical Appliance Co., Ltd. · Oct 2025
CombiSet Hemodialysis Blood Tubing Set
K213992 · Fresenius Medical Care Renal Therapies Group, LLC · May 2023
Tablo Cartridge
K210782 · Outset Medical, Inc. · Nov 2021
SANSIN Tubing Sets for Hemodialysis
K202796 · Jiangxi Sanxin Medtec Co., Ltd. · Sep 2021
NovaLine Tubing Sets for Hemodialysis
K201866 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Mar 2021