Cleared Traditional

K962081 - COMBILINES HEMODIALYSIS BLOOD TUBING SET

K962081 is the FDA 510(k) clearance for COMBILINES HEMODIALYSIS BLOOD TUBING SET by National Medical Care, Medical Products Div., Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K962081 · National Medical Care, Medical Products Div., Inc. · Gastroenterology & Urology device
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Nov 1996
Decision
157d
Days
Class 2
Risk

K962081 is an FDA 510(k) clearance for the COMBILINES HEMODIALYSIS 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, Medical Products Div., Inc. (Rockleigh, US). The FDA issued a Cleared decision on November 1, 1996 after a review of 157 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, Medical Products Div., Inc. devices

Submission Details

510(k) Number K962081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date November 01, 1996
Days to Decision 157 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
27d slower than avg
Panel avg: 130d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 41
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K962081.
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
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631 · B.Braun Medical, Inc. · Apr 1996
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803 · Baxter Healthcare Corp · Dec 1993
HEMODIALYSIS BLOOD TUBING SET
K920797 · National Medical Care, Medical Products Div., Inc. · Sep 1992