Cleared Traditional

K002512 - TORAYSULFONE DIALYZER

K002512 is the FDA 510(k) clearance for TORAYSULFONE DIALYZER 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 426-day FDA review.

K002512 · Toray Industries (America), Inc. · Gastroenterology & Urology device
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Oct 2001
Decision
426d
Days
Class 2
Risk

K002512 is an FDA 510(k) clearance for the TORAYSULFONE DIALYZER. 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 October 15, 2001 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Toray Industries (America), Inc. devices

Submission Details

510(k) Number K002512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date October 15, 2001
Days to Decision 426 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
296d slower than avg
Panel avg: 130d · This submission: 426d
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 K002512.
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CLIRANS E-SERIES DIALYZER
K013550 · Terumo Medical Corp. · Nov 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · Nxstage Medical, Inc. · Oct 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp · Feb 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp. · Feb 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · Nxstage Medical, Inc. · Jan 2001