Cleared Traditional

K944492 - DIALYZER REPROCESSING SYSTEM

K944492 is an FDA 510(k) clearance for DIALYZER REPROCESSING SYSTEM, manufactured by G.E.M. Water Systems. The device is a Class 2 Gastroenterology & Urology device with product code LIF cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K944492 · G.E.M. Water Systems · Gastroenterology & Urology device
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Aug 1995
Decision
349d
Days
Class 2
Risk

K944492 is an FDA 510(k) clearance for the DIALYZER REPROCESSING SYSTEM. Classified as Dialyzer Reprocessing System (product code LIF), Class II - Special Controls.

Submitted by G.E.M. Water Systems (Cypress, US). The FDA issued a Cleared decision on August 28, 1995 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 G.E.M. Water Systems devices

FDA 510(k) Submission Details - K944492

510(k) Number K944492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1994
Decision Date August 28, 1995
Days to Decision 349 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
219d slower than avg
Panel avg: 130d · This submission: 349d
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 K944492.
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
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · Serim Research Corp. · Jun 1991