Cleared Traditional

K971313 - NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET

K971313 is an FDA 510(k) clearance for NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET, manufactured by National Medical Care, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K971313 · National Medical Care, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
201d
Days
Class 2
Risk

K971313 is an FDA 510(k) clearance for the NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by National Medical Care, Inc. (Rockleigh, US). The FDA issued a Cleared decision on October 27, 1997 after a review of 201 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 National Medical Care, Inc. devices

FDA 510(k) Submission Details - K971313

510(k) Number K971313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1997
Decision Date October 27, 1997
Days to Decision 201 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
71d slower than avg
Panel avg: 130d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FJK Device Classification - Class 2, Special Controls

Product Code FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve
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 - FJK Set, Tubing, Blood, With And Without Anti-regurgitation Valve

All 45
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K971313.
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
K001107 · Fresenius Medical Care North America · Jun 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
K000451 · Fresenius Medical Care North America · May 2000
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
K983559 · Icu Medical, Inc. · Dec 1998
COMBILINES HEMODIALYSIS BLOOD TUBING SET
K962081 · National Medical Care, Medical Products Div., Inc. · Nov 1996
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631 · B.Braun Medical, Inc. · Apr 1996
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · Baxter Healthcare Corp · Dec 1993