Cleared Traditional

K820524 - CLIRANS HOLLOW FIBER DIALYZERS

K820524 is an FDA 510(k) clearance for CLIRANS HOLLOW FIBER DIALYZERS, manufactured by Terumo Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K820524 · Terumo Medical Corp. · Gastroenterology & Urology device
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Jul 1982
Decision
132d
Days
Class 2
Risk

K820524 is an FDA 510(k) clearance for the CLIRANS HOLLOW FIBER DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 8, 1982 after a review of 132 days - within the typical 510(k) review window.

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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K820524

510(k) Number K820524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1982
Decision Date July 08, 1982
Days to Decision 132 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
2d slower than avg
Panel avg: 130d · This submission: 132d
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 K820524.
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
K850865 · Erika, Inc. · Apr 1985
TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
K850654 · Erika, Inc. · Mar 1985
TORAY IND. FILTRYZER HOLLOW FIBER ARTIF. KIDNEY B2
K850655 · Erika, Inc. · Mar 1985
ERIKA HPF 50 DIALYZER
K821587 · Erika, Inc. · Jun 1982
HOLLOW FIBER DIALYZERS
K820743 · Terumo Medical Corp. · Jun 1982
ERIKA HPF 100,200,300 DIALYZER
K821690 · Erika, Inc. · Jun 1982