Cleared Traditional

NEPHROSS DIALYZER (K802114) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K802114 · Organon Teknika Corp. · Gastroenterology & Urology device
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Dec 1980
Decision
106d
Days
Class 2
Risk

K802114 is an FDA 510(k) clearance for the NEPHROSS DIALYZER. Classified as Dialyzer, Capillary, Hollow Fiber (product code FJI), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Mchenry, US). The FDA issued a Cleared decision on December 18, 1980 after a review of 106 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 Organon Teknika Corp. devices

Submission Details

510(k) Number K802114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1980
Decision Date December 18, 1980
Days to Decision 106 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
24d faster than avg
Panel avg: 130d · This submission: 106d
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 35
Devices cleared under the same product code (FJI) and FDA review panel - the closest regulatory comparables to K802114.
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
C-DAK TM 2800 ARTIFICIAL KIDNEY
K800704 · Cordis Corp. · May 1980
CF/211 CAPILLARY FLOW DIALYZER, #5M1784
K800221 · Travenol Laboratories, S.A. · Feb 1980
C-DAK 2100 ARTIFICIAL KIDNEY
K792419 · Cordis Corp. · Jan 1980