Cleared Traditional

K954676 - NIPRO ARTERIAL & VENOUS BLOOD TUBING SE...

K954676 is an FDA 510(k) clearance for NIPRO ARTERIAL & VENOUS BLOOD TUBING SE..., manufactured by Nissho Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KOC cleared through the Traditional 510(k) pathway after a 511-day FDA review.

K954676 · Nissho Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
511d
Days
Class 2
Risk

K954676 is an FDA 510(k) clearance for the NIPRO ARTERIAL & VENOUS BLOOD TUBING SET FOR HEMODIALYSIS. Classified as Accessories, Blood Circuit, Hemodialysis (product code KOC), Class II - Special Controls.

Submitted by Nissho Corp. (Miami, US). The FDA issued a Cleared decision on March 4, 1997 after a review of 511 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 Nissho Corp. devices

FDA 510(k) Submission Details - K954676

510(k) Number K954676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 1995
Decision Date March 04, 1997
Days to Decision 511 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
381d slower than avg
Panel avg: 130d · This submission: 511d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOC Device Classification - Class 2, Special Controls

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 123
Devices cleared under the same product code (KOC) and FDA review panel - the closest regulatory comparables to K954676.
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NIPRO BLOOD TUBING SET WITH TRANSDUCER AND SOLUTION SET FOR HEMODIALYSIS
K972206 · Nipro Medical Corp. · Nov 1997
ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS
K955277 · Baxter Healthcare Corp · Feb 1996
DIALYSIS ADMINISTRATION KITS
K952572 · B.Braun Medical, Inc. · Jan 1996
KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA
K950282 · KARL STORZ Endoscopy-America, Inc. · Apr 1995