Cleared Traditional

K001465 - NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET

K001465 is an FDA 510(k) clearance for NIPRO BLOOD TUBING SET FOR HEMODIALYSIS..., manufactured by Nipro Medical Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K001465 · Nipro Medical Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Dec 2000
Decision
209d
Days
Class 2
Risk

K001465 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 December 5, 2000 after a review of 209 days - an extended review 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: 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 Nipro Medical Corp. devices

FDA 510(k) Submission Details - K001465

510(k) Number K001465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2000
Decision Date December 05, 2000
Days to Decision 209 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 131d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FIB Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K001465.
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
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
K010264 · Nipro Medical Corp. · Apr 2001
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
MEDISYSTEMS TRANSDUCER PROTECTOR
K983076 · Medisystems Corp. · Nov 1998