Cleared Traditional

K982340 - EXTRACORPOREAL BLOOD CIRCUIT

K982340 is an FDA 510(k) clearance for EXTRACORPOREAL BLOOD CIRCUIT, manufactured by Haidylena Medical Egypt. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K982340 · Haidylena Medical Egypt · Gastroenterology & Urology device
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Apr 1999
Decision
298d
Days
Class 2
Risk

K982340 is an FDA 510(k) clearance for the EXTRACORPOREAL BLOOD CIRCUIT. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Haidylena Medical Egypt (Nasr City, Cairo, EG). The FDA issued a Cleared decision on April 30, 1999 after a review of 298 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 Haidylena Medical Egypt devices

FDA 510(k) Submission Details - K982340

510(k) Number K982340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1998
Decision Date April 30, 1999
Days to Decision 298 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 130d · This submission: 298d
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 45
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K982340.
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
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
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