Cleared Traditional

HemoCare Hemodialysis System (K233557) - FDA 510(k) Clearance

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

K233557 · Deka Research and Development · Gastroenterology & Urology device
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Jul 2024
Decision
249d
Days
Class 2
Risk

K233557 is an FDA 510(k) clearance for the HemoCare Hemodialysis System. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on July 12, 2024 after a review of 249 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 Deka Research and Development devices

Submission Details

510(k) Number K233557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2023
Decision Date July 12, 2024
Days to Decision 249 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 130d · This submission: 249d
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 K233557.
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
Moda-flx Hemodialysis System and Cartridge
K233798 · Diality, Inc. · Aug 2024
multiFlux 1000 (F00012408)
K240394 · Fresenius Medical Care Renal Therapies Group, LLC · May 2024
Tablo® Hemodialysis System
K232776 · Outset Medical, Inc. · May 2024
NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
K232803 · Nxstage Medical, Inc. · Mar 2024