Cleared Traditional

K971687 - HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME

K971687 is an FDA 510(k) clearance for HEMODIALYSIS VENOUS BLOOD TUBING SET OR..., 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 88-day FDA review.

K971687 · National Medical Care, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
88d
Days
Class 2
Risk

K971687 is an FDA 510(k) clearance for the HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME. 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 July 29, 1997 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 National Medical Care, Inc. devices

FDA 510(k) Submission Details - K971687

510(k) Number K971687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1997
Decision Date July 29, 1997
Days to Decision 88 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
43d faster than avg
Panel avg: 131d · This submission: 88d
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 61
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K971687.
EXTRACORPOREAL BLOOD CIRCUIT
K982340 · Haidylena Medical Egypt · Apr 1999
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
K983559 · Icu Medical, Inc. · Dec 1998
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET
K971313 · National Medical Care, Inc. · Oct 1997
COMBILINES HEMODIALYSIS BLOOD TUBING SET
K962081 · National Medical Care, Medical Products Div., Inc. · Nov 1996
ARTERIAL VENOUS BLOOD TUBING SET
K953823 · Medisystems Corp. · Sep 1996
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631 · B.Braun Medical, Inc. · Apr 1996