Cleared Traditional

K992930 - BIOTEQUE HEMODIALYSIS BLOOD TUBING SET

K992930 is an FDA 510(k) clearance for BIOTEQUE HEMODIALYSIS BLOOD TUBING SET, 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 162-day FDA review.

K992930 · Bioteque Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
162d
Days
Class 2
Risk

K992930 is an FDA 510(k) clearance for the BIOTEQUE HEMODIALYSIS BLOOD TUBING SET. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Bioteque Corp. (Flaggstaff, US). The FDA issued a Cleared decision on February 9, 2000 after a review of 162 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 - K992930

510(k) Number K992930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1999
Decision Date February 09, 2000
Days to Decision 162 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
31d slower than avg
Panel avg: 131d · This submission: 162d
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 K992930.
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
EXEL I.V. BLOOD LINE SET
K992039 · Exelint Intl. Co. · Feb 2000
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