Cleared Traditional

K001971 - HEMODIALYSIS TUBING SETS

K001971 is an FDA 510(k) clearance for HEMODIALYSIS TUBING SETS, manufactured by Ofi Biomedica S.P.A.. The device is a Class 2 Gastroenterology & Urology device with product code FIB cleared through the Traditional 510(k) pathway after a 330-day FDA review.

K001971 · Ofi Biomedica S.P.A. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
330d
Days
Class 2
Risk

K001971 is an FDA 510(k) clearance for the HEMODIALYSIS TUBING SETS. Classified as Protector, Transducer, Dialysis (product code FIB), Class II - Special Controls.

Submitted by Ofi Biomedica S.P.A. (North Attleboro, US). The FDA issued a Cleared decision on May 24, 2001 after a review of 330 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Ofi Biomedica S.P.A. devices

FDA 510(k) Submission Details - K001971

510(k) Number K001971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2000
Decision Date May 24, 2001
Days to Decision 330 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
200d slower than avg
Panel avg: 130d · This submission: 330d
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 13
Devices cleared under the same product code (FIB) and FDA review panel - the closest regulatory comparables to K001971.
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
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
K001465 · Nipro Medical Corp. · Dec 2000
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