Cleared Traditional

K884339 - TORAY FILTRYZER DIALYZERS

K884339 is the FDA 510(k) clearance for TORAY FILTRYZER DIALYZERS by Toray Industries (America), Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K884339 · Toray Industries (America), Inc. · Gastroenterology & Urology device
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Mar 1989
Decision
154d
Days
Class 2
Risk

K884339 is an FDA 510(k) clearance for the TORAY FILTRYZER DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (New York, US). The FDA issued a Cleared decision on March 17, 1989 after a review of 154 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 K884339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1988
Decision Date March 17, 1989
Days to Decision 154 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
24d slower than avg
Panel avg: 130d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FJI Dialyzer, Capillary, Hollow Fiber
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 - FJI Dialyzer, Capillary, Hollow Fiber

All 85
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K884339.
HOLLOW FIBER DIALYZER FOCUS 70H
K893677 · National Medical Care, Medical Products Div., Inc. · Jul 1989
CLIRANS HOLLOW FIBER HEMODIALYZER (WET)
K891477 · Terumo Medical Corp. · Jun 1989
GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY
K892523 · Gambro, Inc. · May 1989
GAMBRO ALWALL GFE 8 & 9 HOLLOW FIBER DIALYZER
K890111 · Gambro, Inc. · Feb 1989
CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100
K883534 · Baxter Healthcare Corp · Oct 1988
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
K883644 · Baxter Healthcare Corp · Oct 1988