Cleared Traditional

FILTRYZER HOLLOW FIBER ARTIF. KIDNEY (K831176) - FDA 510(k) Clearance

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

K831176 · Erika, Inc. · Gastroenterology & Urology device
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Jun 1984
Decision
438d
Days
Class 2
Risk

K831176 is an FDA 510(k) clearance for the FILTRYZER HOLLOW FIBER ARTIF. KIDNEY. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Erika, Inc. (Walker, US). The FDA issued a Cleared decision on June 22, 1984 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Erika, Inc. devices

Submission Details

510(k) Number K831176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1983
Decision Date June 22, 1984
Days to Decision 438 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
308d slower than avg
Panel avg: 130d · This submission: 438d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOC Accessories, Blood Circuit, Hemodialysis
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 - KOC Accessories, Blood Circuit, Hemodialysis

All 37
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K831176.
HOLLOW FIBER DIALYZER
K843632 · Travenol Laboratories, S.A. · Oct 1984
CAPILLARY FLOW DIALYZERS
K840937 · Travenol Laboratories, S.A. · Sep 1984
HOLLOW FIBER DIALYZERS
K840845 · Travenol Laboratories, S.A. · Aug 1984
BSM 2000 DIALYSIS MACHINE
K840062 · Organon Teknika Corp. · Mar 1984
DUAL LUMEN NEEDLE
K833308 · Quinton, Inc. · Dec 1983
CLIRANS MODEL TAF 15 HOLLOW FIBER
K833503 · Terumo Medical Corp. · Dec 1983