Cleared Traditional

K812353 - KF-E SERIES OF HOLLOW FIBER DIALYZERS

K812353 is the FDA 510(k) clearance for KF-E SERIES OF HOLLOW FIBER DIALYZERS by Medisystems Corp.. It is a Class 2 Gastroenterology & Urology device (product code FJI) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K812353 · Medisystems Corp. · Gastroenterology & Urology device
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Sep 1981
Decision
28d
Days
Class 2
Risk

K812353 is an FDA 510(k) clearance for the KF-E SERIES OF HOLLOW FIBER DIALYZERS. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Medisystems Corp. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1981 after a review of 28 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 Medisystems Corp. devices

Submission Details

510(k) Number K812353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1981
Decision Date September 16, 1981
Days to Decision 28 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
102d faster than avg
Panel avg: 130d · This submission: 28d
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 K812353.
HOLLOW FIBER DIALYZERS
K820743 · Terumo Medical Corp. · Jun 1982
ERIKA HPF 100,200,300 DIALYZER
K821690 · Erika, Inc. · Jun 1982
GAMBRO GF-80-M, GF-80-H HEMODIALYZER
K820304 · Gambro, Inc. · Mar 1982
CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY
K802894 · Cordis Corp. · Feb 1981
CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY
K802893 · Cordis Corp. · Feb 1981
C-PAK MODEL 12 ARTIFICIAL KIDNEY
K802613 · Cordis Corp. · Jan 1981