Cleared Traditional

K992016 - AMUKIN D

K992016 is an FDA 510(k) clearance for AMUKIN D, manufactured by Amuchina Intl., Inc.. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K992016 · Amuchina Intl., Inc. · Gastroenterology & Urology device
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Jan 2000
Decision
209d
Days
Class 2
Risk

K992016 is an FDA 510(k) clearance for the AMUKIN D. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by Amuchina Intl., Inc. (Gaithersburg, US). The FDA issued a Cleared decision on January 10, 2000 after a review of 209 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 Amuchina Intl., Inc. devices

FDA 510(k) Submission Details - K992016

510(k) Number K992016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1999
Decision Date January 10, 2000
Days to Decision 209 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 131d · This submission: 209d
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 32
Devices cleared under the same product code (LIF) and FDA review panel - the closest regulatory comparables to K992016.
CLEARFLUX DIALYZER REPROCESSING SYSTEM
K091360 · Novaflux Technologies · Nov 2010
ASSIST HEADER CLEANER
K043126 · Alcavis International, Inc. · Feb 2005
RENACLEAN SH DIALYZER CLEANING SYSTEM
K033505 · Minntech Corp. · Apr 2004
RENACLEAR DIALYZER CLEANING SYSTEM
K991851 · Minntech Corp. · Aug 1999
POTENCY TEST STRIPS, INDICATOR TEST STRIPS
K974426 · Reprocessing Products Corp · Feb 1999
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798 · Environmental Test Systems, Inc. · Mar 1998