FDA Product Code
FDA Product Code FKQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5820
510(k) Clearances — 61 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052764 | DIACAP ULTRA DIALYSIS FLUID FILTER | B. Braun Medizintechnologie GmbH | 2006-06-09 | Traditional | PDF ↗ |
| K893612 | TWO TANK DISSOLUTION MODULE | National Medical Care, Medical Products Div., Inc. | 1989-07-24 | Traditional | PDF ↗ |
| K874084 | MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM | National Medical Care, Medical Products Div., Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K873421 | KAWASUMI A.V. FISTULA SET | Kawasumi Laboratories Co., Ltd. | 1987-10-09 | Traditional | PDF ↗ |
| K870889 | ACID FUCHSIN SOLUTIONS | D.R.G. Scientific Industries | 1987-07-08 | Traditional | PDF ↗ |
| K861730 | ACTRIL FOR KIDNEY MACHINE DISINFECTANT | Renal Systems, Inc. | 1987-06-09 | Traditional | PDF ↗ |
| K864635 | FOUR TANK DISSOLUTION MODULE | National Medical Care, Medical Products Div., Inc. | 1987-01-13 | Traditional | PDF ↗ |
| K862304 | DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM | Cd Medical, Inc. | 1986-09-09 | Traditional | PDF ↗ |
| K861472 | MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 | National Medical Care, Medical Products Div., Inc. | 1986-07-10 | Traditional | PDF ↗ |
| K852359 | AMUCHINA/DIALYZER DISINFECTANT | Amuchina Intl., Inc. | 1986-05-13 | Traditional | PDF ↗ |
| K860296 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | Physicians Surgeons Purchasing Group | 1986-03-04 | Traditional | PDF ↗ |
| K860336 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS | Breem Laboratories | 1986-03-04 | Traditional | PDF ↗ |
| K860297 | HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES | Renal Hygienics | 1986-03-04 | Traditional | PDF ↗ |
| K854391 | HEMODIALYSIS CONCENTRATE | Dana Laboratories | 1986-01-08 | Traditional | PDF ↗ |
| K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | Mesa Medical, Inc. | 1985-09-10 | Traditional | PDF ↗ |
| K852310 | NATURALYTE BICARBONATE CONCENTRATE-DRY PACK | Erika, Inc. | 1985-07-26 | Traditional | PDF ↗ |
| K844734 | ALCIDE REN NEW-D | Alcide Corp. | 1985-05-17 | Traditional | PDF ↗ |
| K844850 | MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT | Medicorp, Inc. | 1985-04-02 | Traditional | PDF ↗ |
| K844750 | FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD | Seratronics, Inc. | 1985-02-15 | Traditional | PDF ↗ |
| K844641 | FRESENIUS HAEMODIALYSIS ;MACHINE A1008 | Seratronics, Inc. | 1985-02-14 | Traditional | PDF ↗ |
| K844748 | NEPHROSS ALLEGRO H.F. | Organon Teknika Corp. | 1985-01-22 | Traditional | PDF ↗ |
| K844756 | ST FAMILY OF HOLLOW FIBER DIALYZERS | Travenol Laboratories, S.A. | 1985-01-16 | Traditional | PDF ↗ |
| K843963 | DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD | Renal Systems, Inc. | 1985-01-07 | Traditional | PDF ↗ |
| K843623 | UNILYTE A | Medical Enterprises, Ltd. | 1984-11-16 | Traditional | PDF ↗ |
| K842225 | HEMODIAL CONCENTRATE MIXING APPARATUS | Lmf Medical Research & Manufacturing, Inc. | 1984-10-02 | Traditional | PDF ↗ |
| K842131 | FORMACLEAR- & MULTIPLE | Rna Medical Corp. | 1984-09-10 | Traditional | PDF ↗ |
| K834455 | MONOXYCHLOROSENE WAREXIN | Guardian Chemical | 1984-07-31 | Traditional | PDF ↗ |
| K842154 | PACKETS FOR THE PREP OF DIALYSATES & | Organon Teknika Corp. | 1984-07-31 | Traditional | PDF ↗ |
| K842058 | HEMODIALYSIS BATH CONCENTRATE SOLUTION | Pharmaceutical Development Systems | 1984-07-26 | Traditional | PDF ↗ |
| K842294 | DIALYSATE ADDITIVES | Dialysis Products, Inc. | 1984-06-28 | Traditional | PDF ↗ |
| K841543 | CONCENTRATE CONDUCTIVITY METER | Renal Systems, Inc. | 1984-05-22 | Traditional | PDF ↗ |
| K840182 | RENAPAK CONCENTRATE MIXING SYS. | Renal Systems, Inc. | 1984-05-02 | Traditional | PDF ↗ |
| K834395 | CHEMLYTE | Diachem Laboratories | 1984-04-20 | Traditional | PDF ↗ |
| K834587 | HEMODIAL CONCENTRATE | Moana Productions, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K840813 | BIOSPAL 1200S | Hospal Medical Corp. | 1984-04-02 | Traditional | PDF ↗ |
| K840811 | BIOSPAL 3000S | Hospal Medical Corp. | 1984-04-02 | Traditional | PDF ↗ |
| K840812 | BIOSPAL 2400S | Hospal Medical Corp. | 1984-04-02 | Traditional | PDF ↗ |
| K840814 | HOSPAL MODEL H1210 | Hospal Medical Corp. | 1984-04-02 | Traditional | PDF ↗ |
| K832663 | GAMMA STERIL. CAPILLARY FLOW DIALY-G15 | Travenol Laboratories, S.A. | 1983-09-12 | Traditional | PDF ↗ |
| K831940 | GAMMA STERILIZED CAPILLARY FLOW DIALYZ | Travenol Laboratories, S.A. | 1983-08-08 | Traditional | PDF ↗ |
| K830908 | BICARBONATE/VARIABLE SODIUM KIT-DM-367 | Extracorporeal Medical Specialities, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K823092 | HEMAFLO BLOOD TUBING SETS | Cobe Laboratories, Inc. | 1982-11-22 | Traditional | PDF ↗ |
| K822851 | DISSCAP 080 | Hospal Medical Corp. | 1982-10-04 | Traditional | PDF ↗ |
| K822535 | CIDEX*DIALYZER DISINFECTING SOLUTION | Surgikos, Inc. | 1982-09-30 | Traditional | PDF ↗ |
| K822485 | HPF 100,200,300 CAPILLARY FLOW DIALYZ | Erika, Inc. | 1982-08-30 | Traditional | PDF ↗ |
| K821834 | MODEL 100 BICARBONATE CONDUCTIVITY | Western Laboratories Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K820966 | DISSCAP 110 | Hospal Medical Corp. | 1982-04-16 | Traditional | PDF ↗ |
| K820965 | DISSCAP 140 | Hospal Medical Corp. | 1982-04-16 | Traditional | PDF ↗ |
| K820769 | GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL | Gambro, Inc. | 1982-04-16 | Traditional | PDF ↗ |
| K812330 | DIALYSATE CONCENTRATE | Central Biological Co. | 1981-09-29 | Traditional | PDF ↗ |
| K811444 | MODEL DM-333 DIALYSIS CONTROL STATION | Extracorporeal Medical Specialities, Inc. | 1981-06-23 | Traditional | PDF ↗ |
| K802297 | PORTADIAL CARRY-ON KIDNEY MACHINE | Alan P. Kendal, Ph.D. | 1981-05-01 | Traditional | PDF ↗ |
| K810612 | HEMOPHRON | Renal Devices, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K810315 | ALTERNATE STERILIZ. FOR CELLULOSE ACET | Cordis Corp. | 1981-03-20 | Traditional | PDF ↗ |
| K800771 | MOD. DM-356 IPS INTERFACE MODULE | Extracorporeal Medical Specialities, Inc. | 1980-05-20 | Traditional | PDF ↗ |
| K792252 | DMS 3000 | Renal Care Corp. | 1980-03-12 | Traditional | PDF ↗ |
| K781176 | PATIENT AID, MODEL DM-351 | Extracorporeal Medical Specialities, Inc. | 1978-09-07 | Traditional | PDF ↗ |
| K780081 | DIALYZING FLUIDE DELIVERY SYSTEM | Travenol Laboratories, S.A. | 1978-03-31 | Traditional | PDF ↗ |
| K772161 | HEMODIALYSIS APPARATUS | Heald Manufacturing, Inc. | 1978-01-03 | Traditional | PDF ↗ |
| K771375 | PRESSURE MODULE 5M1247 | Travenol Laboratories, S.A. | 1977-09-15 | Traditional | PDF ↗ |
| K760965 | BEDSIDE CONSOLES (11-3-910 & 11-3-930) | Seattle Artificial Kidney Supply Co. | 1976-12-06 | Traditional | PDF ↗ |
Product code FKQ · Class II · Gastroenterology, Urology. Data: openFDA.