Cleared Traditional

K013634 - BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBI...

K013634 is the FDA 510(k) clearance for BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBI... by Bioteque Corp.. It is a Class 2 Gastroenterology & Urology device (product code FJK) cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K013634 · Bioteque Corp. · Gastroenterology & Urology device
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Jul 2002
Decision
246d
Days
Class 2
Risk

K013634 is an FDA 510(k) clearance for the BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Bioteque Corp. (Flagstaff, US). The FDA issued a Cleared decision on July 9, 2002 after a review of 246 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 Bioteque Corp. devices

Submission Details

510(k) Number K013634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 05, 2001
Decision Date July 09, 2002
Days to Decision 246 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
116d slower than avg
Panel avg: 130d · This submission: 246d
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 32
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K013634.
Dimesol Tubing Sets for Hemodialysis
K171952 · Dimesol, Inc. · Mar 2018
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc. · Feb 2009
BLOOD TUBING SETS (STERILE FLUID PATH)
K080807 · Nxstage Medical, Inc. · Jul 2008
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