Cleared Traditional Expedited

K983559 - BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR

K983559 is an FDA 510(k) clearance for BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR, manufactured by Icu Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FJK cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K983559 · Icu Medical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
72d
Days
Class 2
Risk

K983559 is an FDA 510(k) clearance for the BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR. Classified as Set, Tubing, Blood, With And Without Anti-regurgitation Valve (product code FJK), Class II - Special Controls.

Submitted by Icu Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on December 24, 1998 after a review of 72 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icu Medical, Inc. devices

FDA 510(k) Submission Details - K983559

510(k) Number K983559 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date December 24, 1998
Days to Decision 72 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
59d faster than avg
Panel avg: 131d · This submission: 72d
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 60
Devices cleared under the same product code (FJK) and FDA review panel - the closest regulatory comparables to K983559.
EXEL I.V. BLOOD LINE SET
K992039 · Exelint Intl. Co. · Feb 2000
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
K992930 · Bioteque Corp. · Feb 2000
EXTRACORPOREAL BLOOD CIRCUIT
K982340 · Haidylena Medical Egypt · Apr 1999
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET
K971313 · National Medical Care, Inc. · Oct 1997
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
K971687 · National Medical Care, Inc. · Jul 1997
COMBILINES HEMODIALYSIS BLOOD TUBING SET
K962081 · National Medical Care, Medical Products Div., Inc. · Nov 1996