Cleared Traditional

NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS (K953996) - FDA 510(k) Clearance

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

K953996 · NIKKISO CO., LTD. · Gastroenterology & Urology device
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Mar 1997
Decision
573d
Days
Class 2
Risk

K953996 is an FDA 510(k) clearance for the NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS. Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by NIKKISO CO., LTD. (Minneapolis, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 573 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - 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 NIKKISO CO., LTD. devices

Submission Details

510(k) Number K953996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 1995
Decision Date March 19, 1997
Days to Decision 573 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
443d slower than avg
Panel avg: 130d · This submission: 573d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
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 - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 78
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K953996.
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K926568 · Baxter Healthcare Corp · Sep 1994
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K911094 · Abbott Laboratories · Apr 1991