Cleared Traditional

K853591 - DIALYZER

K853591 is an FDA 510(k) clearance for DIALYZER, manufactured by Organon Teknika Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FJI cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K853591 · Organon Teknika Corp. · Gastroenterology & Urology device
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Sep 1985
Decision
15d
Days
Class 2
Risk

K853591 is an FDA 510(k) clearance for the DIALYZER, CAPILLARY, HOLLOW FIBER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Oklahoma City, US). The FDA issued a Cleared decision on September 11, 1985 after a review of 15 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 Organon Teknika Corp. devices

FDA 510(k) Submission Details - K853591

510(k) Number K853591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1985
Decision Date September 11, 1985
Days to Decision 15 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
115d faster than avg
Panel avg: 130d · This submission: 15d
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 K853591.
ADVANCED PERFORM HOLLOW FIBER DIALYZER, 019752-5
K861537 · National Medical Care, Medical Products Div., Inc. · Jul 1986
ADVANCED PERFORMANCE HOLLOW FIBER DIALYZER
K861916 · National Medical Care, Medical Products Div., Inc. · Jul 1986
CLIRANS TAF HOLLOW FIBER DIALYZER
K854280 · Terumo Medical Corp. · Dec 1985
DISSCAP 110 DIALYZER
K851380 · Hospal Medical Corp. · Apr 1985
TORAY INDUSTRIES FILTRYZER HOLLOW FIBER KIDNEY B1-
K850865 · Erika, Inc. · Apr 1985
TORAY INDUS. FILTRYZER HOLLOW FIBER ARTIFICIAL KID
K850654 · Erika, Inc. · Mar 1985