Product Code: LIF FDA class 2 21 CFR 876.5820

Dialyzer Reprocessing System

Gastroenterology, Urology

A dialyzer reprocessing system is a device used in dialysis centers to clean, test, and prepare used hemodialysis filters (dialyzers) for reuse by individual patients, including rinsing, disinfecting, and verifying the integrity of the dialyzer membranes. The device is FDA Class 2, representing moderate risk and requiring 510(k) premarket clearance. It carries product code LIF and is regulated under 21 CFR 876.5820 within the Gastroenterology and Urology specialty. No special flags apply to this device.

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FEI Numbers

Registration Numbers

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Basic Information

Product Code: LIF
Device Class: FDA class 2
Regulation Number: 876.5820
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 57 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K091360	CLEARFLUX DIALYZER REPROCESSING SYSTEM	Nov 03, 2010	Substantially Equivalent	Novaflux Technologies
K043126	ASSIST HEADER CLEANER	Feb 03, 2005	Substantially Equivalent	Alcavis International, Inc.
K040660	STERICHEK GLUTARALDEHYDE REAGENT STRIPS	Nov 15, 2004	Substantially Equivalent	Hach Company
K033505	RENACLEAN SH DIALYZER CLEANING SYSTEM	Apr 27, 2004	Substantially Equivalent	Minntech Corp.
K024076	MAKY 21.1 DIALYZER REPROCESSING SYSTEM	Sep 26, 2003	Substantially Equivalent	Hdc Maquinolas, LLC
K013713	ARM AUTOMATIC REPROCESSING MACHINE	Jul 15, 2002	Substantially Equivalent	Alcavis International Incorporated
K992016	AMUKIN D	Jan 10, 2000	Substantially Equivalent	Amuchina Intl., Inc.
K991851	RENACLEAR DIALYZER CLEANING SYSTEM	Aug 30, 1999	Substantially Equivalent	Minntech Corp.
K974426	POTENCY TEST STRIPS, INDICATOR TEST STRIPS	Feb 10, 1999	Substantially Equivalent	Reprocessing Products Corp
K974798	STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS	Mar 20, 1998	Substantially Equivalent	Environmental Test Systems, Inc.
K970799	ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T)	May 14, 1997	Substantially Equivalent	Alexander Mfg. Co.
K955299	DPS 4 DIALYZER PREPARATION SYSTEM	Oct 21, 1996	Substantially Equivalent	Seratronics, Inc.
K931336	DRS 4 DIALYZER REPROCESSING SYSTEM	Apr 18, 1996	Substantially Equivalent	Seratronics, Inc.
K941867	RENALIN REUSE CART	Jan 22, 1996	Substantially Equivalent	Renal Scientific Service, Inc.
K941757	FORMALIN REUSE CART	Jan 22, 1996	Substantially Equivalent	National Medical Care, Medical Products Div., Inc.
K944539	DRS 4 ND DIALYZER REPROCESSING SYSTEM	Nov 29, 1995	Substantially Equivalent	Seratronics, Inc.
K944492	DIALYZER REPROCESSING SYSTEM	Aug 28, 1995	Substantially Equivalent	G.E.M. Water Systems
K923529	DMS DATA MANAGEMENT SYSTEM/DRS-4 DIALYZER REPROCES	Aug 29, 1994	Substantially Equivalent	Seratronics, Inc.
K914123	SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS	Apr 09, 1992	Substantially Equivalent	Serim Research Corp.
K914580	DRS-4 DIALYZER REPROCESSING SYSTEM	Feb 24, 1992	Substantially Equivalent	Seratronics, Inc.
K911629	SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)	Jun 27, 1991	Substantially Equivalent	Serim Research Corp.
K911628	SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)	Jun 27, 1991	Substantially Equivalent	Serim Research Corp.
K905217	FORMASURE TEST REAGENT	Apr 09, 1991	Substantially Equivalent	Di-Chem, Inc.
K902227	SERIM GLUTARALDEHYDE/NEPHREX POTENCY TEST KIT	Apr 02, 1991	Substantially Equivalent	Serim Research Corp.
K904210	RENATRON II DIALYZER REPROCESSING SYSTEM RS 8330	Nov 27, 1990	Substantially Equivalent	Minntech Corp.
K900341	SERIM RESIDUAL PEROXIDE/RENALIN TEST KIT	Jul 11, 1990	Substantially Equivalent	Serim Research Corp.
K884154	TRANSLUMINAL ENDARTERECTOMY DEVICE	Dec 27, 1988	Substantially Equivalent	Thomas J. Fogarty, M.D.
K874573	FRESENIUS PURISTERIL 340 (TM)	Apr 25, 1988	Substantially Equivalent	Seratronics, Inc.
K874034	ADR-22 AUTOMATIC DIALYZER REPROCESSOR	Oct 23, 1987	Substantially Equivalent	Biodynamics Corp.
K870689	HR-3000 REUSE ADAPTOR	Apr 10, 1987	Substantially Equivalent	Colorado Medical, Inc.
K870471	MODIFIED HR-3000 REUSE ADAPTOR	Apr 10, 1987	Substantially Equivalent	Colorado Medical, Inc.
K860674	DRS-4 DIALYZER REPROCESSING SYSTEM	Apr 07, 1986	Substantially Equivalent	Seratronics, Inc.
K860026	ULTRAMAX III, DIALYZER REPROCESSING DEVICE	Mar 14, 1986	Substantially Equivalent	Medicorp, Inc.
K853817	COBE REN NEW-D DISPENSING KIT	Oct 17, 1985	Substantially Equivalent	Cobe Laboratories, Inc.
K853413	RENNEW-D SPORICIDE/DISINFECTANT FOR HEMODIALYZERS	Sep 06, 1985	Substantially Equivalent	Alcide Corp.
K850799	RINSE MACHINE KR-4 KIDNEY RINSE-4	Jul 29, 1985	Substantially Equivalent	Medical Technologies International, Inc.
K850127	FORMA-TAG USP SODIUM CHLORIDE PACKAGE 80GM & 120 G	Mar 20, 1985	Substantially Equivalent	Computer Dialysis Systems, Inc.
K843520	WAREXIN RECOMMENDED ALTERNATIVE DIALYZ	Oct 04, 1984	Substantially Equivalent	Mesa Medical, Inc.
K841153	ADAPTOR HR-3000 REUSE	Jul 16, 1984	Substantially Equivalent	Colorado Medical, Inc.
K842258	RENATRON	Jul 06, 1984	Substantially Equivalent	Renal Systems, Inc.
K833128	FORMA-FAS-TEST	Jun 27, 1984	Substantially Equivalent	Chemical Detection & Experimentation
K832705	ULTRAMAX	Jun 25, 1984	Substantially Equivalent	Medicorp, Inc.
K834447	ECHO MM1000	Mar 23, 1984	Substantially Equivalent	Mesa Medical, Inc.
K833181	HPR HOME PATIENT RENATRON	Oct 27, 1983	Substantially Equivalent	Renal Systems, Inc.
K832230	DIALYZER PREPARATION SYS DPS-4	Oct 14, 1983	Substantially Equivalent	Seratronics, Inc.
K831132	COMPUDIAL/KP-1	Aug 08, 1983	Substantially Equivalent	Computer Dialysis Systems, Inc.
K830722	SPORIDIDIN-D COLD STERILIZING/SOLUTION	Jun 30, 1983	Substantially Equivalent	Sporicidin Intl.
K830190	AHR-3000 RE-USE ADAPTOR	May 27, 1983	Substantially Equivalent	Colorado Medical, Inc.
K830575	RENALIN (TENTATIVE	Mar 31, 1983	Substantially Equivalent	Renal Systems, Inc.
K830574	RENATRON DIALYZER REPROCESSING SYS	Mar 29, 1983	Substantially Equivalent	Renal Systems, Inc.
K821863	DIALYZER REPROCESSING SYSTEM DRS-4	Oct 18, 1982	Substantially Equivalent	Seratronics, Inc.
K821383	ECHO, MODEL MM-1000	Jun 23, 1982	Substantially Equivalent	Mesa Medical, Inc.
K820695	AUTOMATIC DIALYZER REPROCESSOR #ADR-22	Apr 29, 1982	Substantially Equivalent	Texas Medical Devices, Inc.
K820221	HYDROGEN PEROXIDE TOPICAL; FORMALDEHYDE	Mar 23, 1982	Substantially Equivalent	Renal Systems, Inc.
K813107	COMPUDIAL/KP-1	Mar 23, 1982	Substantially Equivalent	Computer Dialysis Systems, Inc.
K812230	MODEL RS 8300	Nov 06, 1981	Substantially Equivalent	Renal Systems, Inc.
K802828	LIXIVITRON	May 08, 1981	Substantially Equivalent	United Medical