Cleared Traditional

K010264 - NIPRO BLOOD TUBING SET FOR HEMODIALYSIS...

K010264 is the FDA 510(k) clearance for NIPRO BLOOD TUBING SET FOR HEMODIALYSIS... by Nipro Medical Corp.. It is a Class 2 Gastroenterology & Urology device (product code FIB) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K010264 · Nipro Medical Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2001
Decision
88d
Days
Class 2
Risk

K010264 is an FDA 510(k) clearance for the NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMIN.... Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Nipro Medical Corp. (Weston, US). The FDA issued a Cleared decision on April 27, 2001 after a review of 88 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 Nipro Medical Corp. devices

Submission Details

510(k) Number K010264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2001
Decision Date April 27, 2001
Days to Decision 88 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
42d faster than avg
Panel avg: 130d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FIB Protector, Transducer, Dialysis
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 - FIB Protector, Transducer, Dialysis

All 11
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K010264.
NovaLine SP-C35 Transducer Protector (956007)
K240164 · Bain Medical Equipment (Guangzhou) Co., Ltd. · Jun 2024
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988 · Nipro Medical Corporation · Feb 2008
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · Fresenius Medical Care North America · Dec 2000
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR
K000702 · Fresenius Medical Care North America · Jun 2000
MILLEX, DUALEX (PLUS, ULTRA)
K934069 · Millipore Corp. · Apr 1994
TRANSDUCER PROTECTOR
K910821 · Gelman Sciences, Inc. · Aug 1991