Panels › Gastroenterology, Urology › Product code FKQ · Class 2
System, Dialysate Delivery, Central Multiple Patient
Regulation 876.5820
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in FKQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Hospal Medical Corp. | 7 | 0 |
| Travenol Laboratories, S.A. | 5 | 0 |
| Extracorporeal Medical Specialities, Inc. | 4 | 0 |
| National Medical Care, Medical Products Div., Inc. | 4 | 0 |
| Renal Systems, Inc. | 4 | 0 |
| Erika, Inc. | 2 | 0 |
| Organon Teknika Corp. | 2 | 0 |
| Seratronics, Inc. | 2 | 0 |
| Alan P. Kendal, Ph.D. | 1 | 0 |
| Alcide Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 9, 2006 | K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER B. Braun Medizintechnologie GmbH, DE | FKQ |
| Jul 24, 1989 | K893612 | TWO TANK DISSOLUTION MODULE National Medical Care, Medical Products Div., Inc. | FKQ |
| Apr 27, 1988 | K874084 | MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM National Medical Care, Medical Products Div., Inc. | FKQ |
| Oct 9, 1987 | K873421 | KAWASUMI A.V. FISTULA SET Kawasumi Laboratories Co., Ltd. | FKQ |
| Jul 8, 1987 | K870889 | ACID FUCHSIN SOLUTIONS D.R.G. Scientific Industries | FKQ |
| Jun 9, 1987 | K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT Renal Systems, Inc. | FKQ |
| Jan 13, 1987 | K864635 | FOUR TANK DISSOLUTION MODULE National Medical Care, Medical Products Div., Inc. | FKQ |
| Sep 9, 1986 | K862304 | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM Cd Medical, Inc. | FKQ |
| Jul 10, 1986 | K861472 | MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 National Medical Care, Medical Products Div., Inc. | FKQ |
| May 13, 1986 | K852359 | AMUCHINA/DIALYZER DISINFECTANT Amuchina Intl., Inc. | FKQ |
| Mar 4, 1986 | K860336 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS Breem Laboratories | FKQ |
| Mar 4, 1986 | K860297 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES Renal Hygienics | FKQ |
| Mar 4, 1986 | K860296 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES Physicians Surgeons Purchasing Group | FKQ |
| Jan 8, 1986 | K854391 | HEMODIALYSIS CONCENTRATE Dana Laboratories | FKQ |
| Sep 10, 1985 | K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT Mesa Medical, Inc. | FKQ |
| Jul 26, 1985 | K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK Erika, Inc. | FKQ |
| May 17, 1985 | K844734 | ALCIDE REN NEW-D Alcide Corp. | FKQ |
| Apr 2, 1985 | K844850 | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT Medicorp, Inc. | FKQ |
| Feb 15, 1985 | K844750 | FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD Seratronics, Inc. | FKQ |
| Feb 14, 1985 | K844641 | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 Seratronics, Inc. | FKQ |
| Jan 22, 1985 | K844748 | NEPHROSS ALLEGRO H.F. Organon Teknika Corp. | FKQ |
| Jan 16, 1985 | K844756 | ST FAMILY OF HOLLOW FIBER DIALYZERS Travenol Laboratories, S.A. | FKQ |
| Jan 7, 1985 | K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD Renal Systems, Inc. | FKQ |
| Nov 16, 1984 | K843623 | UNILYTE A Medical Enterprises, Ltd. | FKQ |
| Oct 2, 1984 | K842225 | HEMODIAL CONCENTRATE MIXING APPARATUS Lmf Medical Research & Manufacturing, Inc. | FKQ |
| Sep 10, 1984 | K842131 | FORMACLEAR- & MULTIPLE Rna Medical Corp. | FKQ |
| Jul 31, 1984 | K842154 | PACKETS FOR THE PREP OF DIALYSATES & Organon Teknika Corp. | FKQ |
| Jul 31, 1984 | K834455 | MONOXYCHLOROSENE WAREXIN Guardian Chemical | FKQ |
| Jul 26, 1984 | K842058 | HEMODIALYSIS BATH CONCENTRATE SOLUTION Pharmaceutical Development Systems | FKQ |
| Jun 28, 1984 | K842294 | DIALYSATE ADDITIVES Dialysis Products, Inc. | FKQ |
| May 22, 1984 | K841543 | CONCENTRATE CONDUCTIVITY METER Renal Systems, Inc. | FKQ |
| May 2, 1984 | K840182 | RENAPAK CONCENTRATE MIXING SYS. Renal Systems, Inc. | FKQ |
| Apr 20, 1984 | K834395 | CHEMLYTE Diachem Laboratories | FKQ |
| Apr 13, 1984 | K834587 | HEMODIAL CONCENTRATE Moana Productions, Inc. | FKQ |
| Apr 2, 1984 | K840814 | HOSPAL MODEL H1210 Hospal Medical Corp. | FKQ |
| Apr 2, 1984 | K840813 | BIOSPAL 1200S Hospal Medical Corp. | FKQ |
| Apr 2, 1984 | K840812 | BIOSPAL 2400S Hospal Medical Corp. | FKQ |
| Apr 2, 1984 | K840811 | BIOSPAL 3000S Hospal Medical Corp. | FKQ |
| Sep 12, 1983 | K832663 | GAMMA STERIL. CAPILLARY FLOW DIALY-G15 Travenol Laboratories, S.A. | FKQ |
| Aug 8, 1983 | K831940 | GAMMA STERILIZED CAPILLARY FLOW DIALYZ Travenol Laboratories, S.A. | FKQ |
| Jun 8, 1983 | K830908 | BICARBONATE/VARIABLE SODIUM KIT-DM-367 Extracorporeal Medical Specialities, Inc. | FKQ |
| Nov 22, 1982 | K823092 | HEMAFLO BLOOD TUBING SETS Cobe Laboratories, Inc. | FKQ |
| Oct 4, 1982 | K822851 | DISSCAP 080 Hospal Medical Corp. | FKQ |
| Sep 30, 1982 | K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION Surgikos, Inc. | FKQ |
| Aug 30, 1982 | K822485 | HPF 100,200,300 CAPILLARY FLOW DIALYZ Erika, Inc. | FKQ |
| Jul 2, 1982 | K821834 | MODEL 100 BICARBONATE CONDUCTIVITY Western Laboratories Corp. | FKQ |
| Apr 16, 1982 | K820966 | DISSCAP 110 Hospal Medical Corp. | FKQ |
| Apr 16, 1982 | K820965 | DISSCAP 140 Hospal Medical Corp. | FKQ |
| Apr 16, 1982 | K820769 | GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL Gambro, Inc. | FKQ |
| Sep 29, 1981 | K812330 | DIALYSATE CONCENTRATE Central Biological Co. | FKQ |
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