Cleared Traditional

K850654 - TORAY INDUS. FILTRYZER HOLLOW FIBER ART...

K850654 is an FDA 510(k) clearance for TORAY INDUS. FILTRYZER HOLLOW FIBER ART..., manufactured by Erika, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K850654 · Erika, Inc. · Gastroenterology & Urology device
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Mar 1985
Decision
16d
Days
Class 2
Risk

K850654 is an FDA 510(k) clearance for the TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Erika, Inc. (Rockleigh, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 16 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 Erika, Inc. devices

FDA 510(k) Submission Details - K850654

510(k) Number K850654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date March 07, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 130d · This submission: 16d
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 97
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K850654.
DIALYZER, CAPILLARY, HOLLOW FIBER
K853591 · Organon Teknika Corp. · Sep 1985
DISSCAP 110 DIALYZER
K851380 · Hospal Medical Corp. · Apr 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
K850865 · Erika, Inc. · Apr 1985
TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2
K850655 · Erika, Inc. · Mar 1985
CLIRANS HOLLOW FIBER DIALYZERS
K820524 · Terumo Medical Corp. · Jul 1982
ERIKA HPF 50 DIALYZER
K821587 · Erika, Inc. · Jun 1982