Cleared Traditional

K043126 - ASSIST HEADER CLEANER

K043126 is an FDA 510(k) clearance for ASSIST HEADER CLEANER, manufactured by Alcavis International, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K043126 · Alcavis International, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
83d
Days
Class 2
Risk

K043126 is an FDA 510(k) clearance for the ASSIST HEADER CLEANER. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Alcavis International, Inc. (Gaithersburg, US). The FDA issued a Cleared decision on February 3, 2005 after a review of 83 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 Alcavis International, Inc. devices

FDA 510(k) Submission Details - K043126

510(k) Number K043126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2004
Decision Date February 03, 2005
Days to Decision 83 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
47d faster than avg
Panel avg: 130d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIF Device Classification - Class 2, Special Controls

Product Code LIF Dialyzer Reprocessing System
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 - LIF Dialyzer Reprocessing System

All 17
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K043126.
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505 · Minntech Corp. · Apr 2004
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · Minntech Corp. · Aug 1999
ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)
K970799 · Alexander Mfg. Co. · May 1997
FORMALIN REUSE CART
K941757 · National Medical Care, Medical Products Div., Inc. · Jan 1996
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123 · Serim Research Corp. · Apr 1992
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · Serim Research Corp. · Jun 1991