Cleared Traditional

K883407 - TORAY FILTRYZER BK SERIES

K883407 is the FDA 510(k) clearance for TORAY FILTRYZER BK SERIES 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 200-day FDA review.

K883407 · Toray Industries (America), Inc. · Gastroenterology & Urology device
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Feb 1989
Decision
200d
Days
Class 2
Risk

K883407 is an FDA 510(k) clearance for the TORAY FILTRYZER BK SERIES. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (New York, US). The FDA issued a Cleared decision on February 27, 1989 after a review of 200 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 K883407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1988
Decision Date February 27, 1989
Days to Decision 200 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 130d · This submission: 200d
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 K883407.
HOLLOW FIBER DIALYZER SERIES FOCUS 160/160H
K895759 · National Medical Care, Medical Products Div., Inc. · Nov 1989
FILTRAL TM 20 HEMODIALYZER/FILTER
K893742 · Hospal Medical Corp. · Jul 1989
FRESENIUS HEMOFLOW, F40M, F50M, F60M & F80M
K892262 · Fresenius USA, Inc. · Apr 1989
CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G
K890315 · Baxter Healthcare Corp · Feb 1989
MULTIFLOW(TM) 60 KIT
K884365 · Hospal Medical Corp. · Dec 1988
FILTRAL TM 8 HEMODIALYZER
K884326 · Hospal Medical Corp. · Dec 1988