Cleared Traditional

K935471 - FILTRYZER(TM)

K935471 is an FDA 510(k) clearance for FILTRYZER(TM), manufactured by Toray Industries (America), Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 550-day FDA review.

K935471 · Toray Industries (America), Inc. · Gastroenterology & Urology device
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May 1995
Decision
550d
Days
Class 2
Risk

K935471 is an FDA 510(k) clearance for the FILTRYZER(TM). Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Toray Industries (America), Inc. (Otsu-Shi, Shiga-Ken 520, JP). The FDA issued a Cleared decision on May 19, 1995 after a review of 550 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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: 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

FDA 510(k) Submission Details - K935471

510(k) Number K935471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1993
Decision Date May 19, 1995
Days to Decision 550 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
419d slower than avg
Panel avg: 131d · This submission: 550d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJI Device Classification - Class 2, Special Controls

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 117
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K935471.
COBE CENTRYSYSTEM CS 200 DIALYZER
K944436 · Cobe Renal Care, Inc. · Jan 1996
FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALYZER
K952343 · National Medical Care, Medical Products Div., Inc. · Dec 1995
MCA(TM) 180 HEMODIALYZER
K945622 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
MCA(TM) 130 HEMODIALYZER
K945623 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
MCA(TM) 160 HEMODIALYZER
K945624 · Althin Medical AB an Affiliate of Baxter Intl · May 1995
155 SCE(TM) HEMODIALYZER
K945631 · Althin Medical AB an Affiliate of Baxter Intl · May 1995