Cleared Traditional

K994198 - HEMOFEEL-CH

K994198 is the FDA 510(k) clearance for HEMOFEEL-CH by Toray Industries (America), Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDI) cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K994198 · Toray Industries (America), Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
256d
Days
Class 2
Risk

K994198 is an FDA 510(k) clearance for the HEMOFEEL-CH, MODELS CH-0.35L, CH-0.6L, CH-1.0L. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (Bellaire, US). The FDA issued a Cleared decision on August 25, 2000 after a review of 256 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 Toray Industries (America), Inc. devices

Submission Details

510(k) Number K994198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1999
Decision Date August 25, 2000
Days to Decision 256 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 130d · This submission: 256d
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 199
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K994198.
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · Nxstage Medical, Inc. · Jan 2001
FRESENIUS OPTIFLUX 200A
K003498 · Fresenius Medical Care North America · Jan 2001
FRESENIUS OPTIFLUX 200NR
K002277 · Fresenius Medical Care North America · Aug 2000
PSN HEMODIALYZER, MODELS PSN 170, PSN 210
K001422 · Baxter Healthcare Corp · Jun 2000
RENAFLO II HF 2000 HEMOFILTER
K000028 · Minntech Corp. · Apr 2000
MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576
K992894 · Baxter Healthcare Corp · Nov 1999