Dialyzer Reprocessing System
FDA product code LIF · Class II (moderate risk) · 21 CFR 876.5820 · Gastroenterology, Urology
57510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Seratronics, Inc. 9
- Renal Systems, Inc. 6
- Serim Research Corp. 5
- Colorado Medical, Inc. 4
- Computer Dialysis Systems, Inc. 3
- Minntech Corp. 3
- Mesa Medical, Inc. 3
- Alcavis International, Inc. 2
- Medicorp, Inc. 2
- Chemical Detection & Experimentation 1
- Medical Technologies International, Inc. 1
- Alcide Corp. 1
- Cobe Laboratories, Inc. 1
- Biodynamics Corp. 1
- Thomas J. Fogarty, M.D. 1
- Sporicidin Intl. 1
- Texas Medical Devices, Inc. 1
- Di-Chem, Inc. 1
- G.E.M. Water Systems 1
- Novaflux Technologies 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K091360 | Clearflux Dialyzer Reprocessing SystemLIF · Traditional | Novaflux Technologies | 11/03/2010SE |
| K043126 | Assist Header CleanerLIF · Traditional | Alcavis International, Inc. | 02/03/2005SE |
| K040660 | Sterichek Glutaraldehyde Reagent StripsLIF · Traditional | Hach Company | 11/15/2004SE |
| K033505 | Renaclean SH Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 04/27/2004SE |
| K024076 | Maky 21.1 Dialyzer Reprocessing SystemLIF · Traditional | Hdc Maquinolas, LLC | 09/26/2003SE |
| K013713 | Arm Automatic Reprocessing MachineLIF · Traditional | Alcavis International Incorporated | 07/15/2002SE |
| K992016 | Amukin DLIF · Traditional | Amuchina Intl., Inc. | 01/10/2000SE |
| K991851 | Renaclear Dialyzer Cleaning SystemLIF · Traditional | Minntech Corp. | 08/30/1999SE |
| K974426 | Potency Test Strips, Indicator Test StripsLIF · Traditional | Reprocessing Products Corp | 02/10/1999SE |
| K974798 | Sterichek(Tm) Residual Peroxide Reagent StrpsLIF · Traditional | Environmental Test Systems, Inc. | 03/20/1998SE |
| K970799 | Alexander Manufacturing Rechargeable Battery (M1/T)LIF · Traditional | Alexander Mfg. Co. | 05/14/1997SE |
| K955299 | DPS 4 Dialyzer Preparation SystemLIF · Traditional | Seratronics, Inc. | 10/21/1996SE |
| K931336 | DRS 4 Dialyzer Reprocessing SystemLIF · Traditional | Seratronics, Inc. | 04/18/1996SE |
| K941867 | Renalin Reuse CartLIF · Traditional | Renal Scientific Service, Inc. | 01/22/1996SE |
| K941757 | Formalin Reuse CartLIF · Traditional | National Medical Care, Medical Products Div., Inc. | 01/22/1996SE |
| K944539 | DRS 4 ND Dialyzer Reprocessing SystemLIF · Traditional | Seratronics, Inc. | 11/29/1995SE |
| K944492 | Dialyzer Reprocessing SystemLIF · Traditional | G.E.M. Water Systems | 08/28/1995SE |
| K923529 | DMS Data Management SYSTEM/DRS-4 Dialyzer ReprocesLIF · Traditional | Seratronics, Inc. | 08/29/1994SE |
| K914123 | Serim Residual Formaldehyde Reagent StripsLIF · Traditional | Serim Research Corp. | 04/09/1992SE |
| K914580 | DRS-4 Dialyzer Reprocessing SystemLIF · Traditional | Seratronics, Inc. | 02/24/1992SE |
| K911629 | Serim Formaldehyde Reagent Strips (2.5% -4.0%)LIF · Traditional | Serim Research Corp. | 06/27/1991SE |
| K911628 | Serim Formaldehyde Reagent Strips (1.O% -2.0%)LIF · Traditional | Serim Research Corp. | 06/27/1991SE |
| K905217 | Formasure Test ReagentLIF · Traditional | Di-Chem, Inc. | 04/09/1991SE |
| K902227 | Serim Glutaraldehyde/Nephrex Potency Test KitLIF · Traditional | Serim Research Corp. | 04/02/1991SE |
| K904210 | Renatron II Dialyzer Reprocessing System RS 8330LIF · Traditional | Minntech Corp. | 11/27/1990SE |
| K900341 | Serim Residual Peroxide/Renalin Test KitLIF · Traditional | Serim Research Corp. | 07/11/1990SE |
| K884154 | Transluminal Endarterectomy DeviceLIF · Traditional | Thomas J. Fogarty, M.D. | 12/27/1988SE |
| K874573 | Fresenius Puristeril 340 (TM)LIF · Traditional | Seratronics, Inc. | 04/25/1988SE |
| K874034 | ADR-22 Automatic Dialyzer ReprocessorLIF · Traditional | Biodynamics Corp. | 10/23/1987SE |
| K870689 | HR-3000 Reuse AdaptorLIF · Traditional | Colorado Medical, Inc. | 04/10/1987SE |
| K870471 | Modified HR-3000 Reuse AdaptorLIF · Traditional | Colorado Medical, Inc. | 04/10/1987SE |
| K860674 | DRS-4 Dialyzer Reprocessing SystemLIF · Traditional | Seratronics, Inc. | 04/07/1986SE |
| K860026 | Ultramax III, Dialyzer Reprocessing DeviceLIF · Traditional | Medicorp, Inc. | 03/14/1986SE |
| K853817 | Cobe Ren New-D Dispensing KitLIF · Traditional | Cobe Laboratories, Inc. | 10/17/1985SE |
| K853413 | Rennew-D Sporicide/Disinfectant for HemodialyzersLIF · Traditional | Alcide Corp. | 09/06/1985SE |
| K850799 | Rinse Machine KR-4 Kidney RINSE-4LIF · Traditional | Medical Technologies International, Inc. | 07/29/1985SE |
| K850127 | Forma-Tag Usp Sodium Chloride Package 80GM & 120 GLIF · Traditional | Computer Dialysis Systems, Inc. | 03/20/1985SE |
| K843520 | Warexin Recommended Alternative DialyzLIF · Traditional | Mesa Medical, Inc. | 10/04/1984SE |
| K841153 | Adaptor HR-3000 ReuseLIF · Traditional | Colorado Medical, Inc. | 07/16/1984SE |
| K842258 | RenatronLIF · Traditional | Renal Systems, Inc. | 07/06/1984SE |
| K833128 | Forma-Fas-TestLIF · Traditional | Chemical Detection & Experimentation | 06/27/1984SE |
| K832705 | UltramaxLIF · Traditional | Medicorp, Inc. | 06/25/1984SE |
| K834447 | Echo MM1000LIF · Traditional | Mesa Medical, Inc. | 03/23/1984SE |
| K833181 | HPR Home Patient RenatronLIF · Traditional | Renal Systems, Inc. | 10/27/1983SE |
| K832230 | Dialyzer Preparation Sys DPS-4LIF · Traditional | Seratronics, Inc. | 10/14/1983SE |
| K831132 | COMPUDIAL/KP-1LIF · Traditional | Computer Dialysis Systems, Inc. | 08/08/1983SE |
| K830722 | Sporididin-D Cold Sterilizing/SolutionLIF · Traditional | Sporicidin Intl. | 06/30/1983SE |
| K830190 | AHR-3000 Re-Use AdaptorLIF · Traditional | Colorado Medical, Inc. | 05/27/1983SE |
| K830575 | Renalin (TentativeLIF · Traditional | Renal Systems, Inc. | 03/31/1983SE |
| K830574 | Renatron Dialyzer Reprocessing SysLIF · Traditional | Renal Systems, Inc. | 03/29/1983SE |
| K821863 | Dialyzer Reprocessing System DRS-4LIF · Traditional | Seratronics, Inc. | 10/18/1982SE |
| K821383 | Echo, Model MM-1000LIF · Traditional | Mesa Medical, Inc. | 06/23/1982SE |
| K820695 | Automatic Dialyzer Reprocessor #ADR-22LIF · Traditional | Texas Medical Devices, Inc. | 04/29/1982SE |
| K820221 | Hydrogen Peroxide Topical; FormaldehydeLIF · Traditional | Renal Systems, Inc. | 03/23/1982SE |
| K813107 | COMPUDIAL/KP-1LIF · Traditional | Computer Dialysis Systems, Inc. | 03/23/1982SE |
| K812230 | Model RS 8300LIF · Traditional | Renal Systems, Inc. | 11/06/1981SE |
| K802828 | LixivitronLIF · Traditional | United Medical | 05/08/1981SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2016-2009 | HACH SteriChek Residual Peroxide Reagent Strips, 5/100-strip bottles per kit, Kit Part…Some of the reagent strip bottles contain the incorrect strips | Hach Co | 04/21/2009Terminated |