Cleared Traditional

K882158 - MODIFIED TORAY FILTRYZER DIALYZERS

K882158 is the FDA 510(k) clearance for MODIFIED 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 81-day FDA review.

K882158 · Toray Industries (America), Inc. · Gastroenterology & Urology device
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Aug 1988
Decision
81d
Days
Class 2
Risk

K882158 is an FDA 510(k) clearance for the MODIFIED 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 August 12, 1988 after a review of 81 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Toray Industries (America), Inc. devices

Submission Details

510(k) Number K882158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1988
Decision Date August 12, 1988
Days to Decision 81 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
49d faster than avg
Panel avg: 130d · This submission: 81d
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 K882158.
CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170
K883644 · Baxter Healthcare Corp · Oct 1988
GAMBRO ALWALL GFE 12 & 18 HOLLOW FIBER DIALYZER
K883589 · Gambro, Inc. · Sep 1988
COBE CENTRYSYSTEM HOLLOW FIBER DIALYZERS
K881811 · Cobe Laboratories, Inc. · Sep 1988
ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA
K882680 · Baxter Healthcare Corp · Jul 1988
NEPHROSS I.Q. ALLEGO
K882213 · Organon Teknika Corp. · Jun 1988
NEPHROSS I.Q. MODERATO
K882215 · Organon Teknika Corp. · Jun 1988