Product code FKQ
- Device name
- System, Dialysate Delivery, Central Multiple Patient
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | B. Braun Medizintechnologie GmbH | 2006-06-09 |
| K893612 | TWO TANK DISSOLUTION MODULE | National Medical Care, Medical Products Div., Inc. | 1989-07-24 |
| K874084 | MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM | National Medical Care, Medical Products Div., Inc. | 1988-04-27 |
| K873421 | KAWASUMI A.V. FISTULA SET | Kawasumi Laboratories Co., Ltd. | 1987-10-09 |
| K870889 | ACID FUCHSIN SOLUTIONS | D.R.G. Scientific Industries | 1987-07-08 |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | Renal Systems, Inc. | 1987-06-09 |
| K864635 | FOUR TANK DISSOLUTION MODULE | National Medical Care, Medical Products Div., Inc. | 1987-01-13 |
| K862304 | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM | Cd Medical, Inc. | 1986-09-09 |
| K861472 | MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 | National Medical Care, Medical Products Div., Inc. | 1986-07-10 |
| K852359 | AMUCHINA/DIALYZER DISINFECTANT | Amuchina Intl., Inc. | 1986-05-13 |
| K860296 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | Physicians Surgeons Purchasing Group | 1986-03-04 |
| K860297 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | Renal Hygienics | 1986-03-04 |
| K860336 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS | Breem Laboratories | 1986-03-04 |
| K854391 | HEMODIALYSIS CONCENTRATE | Dana Laboratories | 1986-01-08 |
| K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | Mesa Medical, Inc. | 1985-09-10 |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | Erika, Inc. | 1985-07-26 |
| K844734 | ALCIDE REN NEW-D | Alcide Corp. | 1985-05-17 |
| K844850 | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT | Medicorp, Inc. | 1985-04-02 |
| K844750 | FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD | Seratronics, Inc. | 1985-02-15 |
| K844641 | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 | Seratronics, Inc. | 1985-02-14 |
| K844748 | NEPHROSS ALLEGRO H.F. | Organon Teknika Corp. | 1985-01-22 |
| K844756 | ST FAMILY OF HOLLOW FIBER DIALYZERS | Travenol Laboratories, S.A. | 1985-01-16 |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | Renal Systems, Inc. | 1985-01-07 |
| K843623 | UNILYTE A | Medical Enterprises, Ltd. | 1984-11-16 |
| K842225 | HEMODIAL CONCENTRATE MIXING APPARATUS | Lmf Medical Research & Manufacturing, Inc. | 1984-10-02 |
| K842131 | FORMACLEAR- & MULTIPLE | Rna Medical Corp. | 1984-09-10 |
| K834455 | MONOXYCHLOROSENE WAREXIN | Guardian Chemical | 1984-07-31 |
| K842154 | PACKETS FOR THE PREP OF DIALYSATES & | Organon Teknika Corp. | 1984-07-31 |
| K842058 | HEMODIALYSIS BATH CONCENTRATE SOLUTION | Pharmaceutical Development Systems | 1984-07-26 |
| K842294 | DIALYSATE ADDITIVES | Dialysis Products, Inc. | 1984-06-28 |
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| 00677964000508 | Centrisol Acid Concentrate | MEDIVATORS INC. | 2016-09-20 |
| 00677964000492 | Centrisol Acid Concentrate | MEDIVATORS INC. | 2016-09-20 |
| 00677964000485 | Centrisol Acid Concentrate | MEDIVATORS INC. | 2016-09-20 |
| 00677964000409 | Centrisol Liquid Bicarbonate Concentrate | MEDIVATORS INC. | 2016-09-20 |
| 00677964000393 | Renasol Liquid Bicarbonate Concentrate | MEDIVATORS INC. | 2016-09-20 |
| 00677964000355 | Renasol Bicarbonate Concentrate Powder | MEDIVATORS INC. | 2016-09-20 |
| 00677964000348 | Renasol Bicarbonate Concentrate Powder | MEDIVATORS INC. | 2016-09-20 |
| 00677964000331 | Renasol Bicarbonate Concentrate Powder | MEDIVATORS INC. | 2016-09-20 |
| 00677964000324 | Centrisol Bicarbonate Concentrate Powder | MEDIVATORS INC. | 2016-09-20 |
| 00677964000317 | Centrisol Bicarbonate Concentrate Powder | MEDIVATORS INC. | 2016-09-20 |
| 00677964000300 | Centrisol Bicarbonate Concentrate Powder | MEDIVATORS INC. | 2016-09-20 |