Cleared Traditional

K013634 - BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK

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

K013634 · Bioteque Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K013634

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
115d slower than avg
Panel avg: 131d · This submission: 246d
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 57
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K013634.
GAMBRO CARTRIDGE BLOOD SETS
K070414 · Gambro Renal Products · Oct 2007
NIPRO BLOOD TUBING SET WITH TRANSDUCER PROTECTOR AND PRIMING SET, MODEL A201-A219, V801-V806, 5M9634, 5M9693
K072024 · Nipro Medical Corp. · Oct 2007
GAMBRO QUICKSET BLOODLINES
K063290 · Gambro Renal Products · Jan 2007
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
K012242 · Fresenius Medical Care North America · Aug 2001
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
K001873 · Fresenius Medical Care North America · Jul 2000
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