Atlas FDA

FKQ

61 FDA 510(k) clearances · Product code

54 daysmedian time to decision
164 days90th percentile
61clearances measured

FDA profile

Official device name
System, Dialysate Delivery, Central Multiple Patient
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
1994: 2 · 2000: 1 · 2001: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DIACAP ULTRA DIALYSIS FLUID FILTER (K052764)B. Braun Medizintechnologie GmbH2006-06-09
TWO TANK DISSOLUTION MODULE (K893612)National Medical Care, Medical Products Div., Inc.1989-07-24
MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM (K874084)National Medical Care, Medical Products Div., Inc.1988-04-27
KAWASUMI A.V. FISTULA SET (K873421)Kawasumi Laboratories Co., Ltd.1987-10-09
ACID FUCHSIN SOLUTIONS (K870889)D.R.G. Scientific Industries1987-07-08
ACTRIL FOR KIDNEY MACHINE DISINFECTANT (K861730)Renal Systems, Inc.1987-06-09
FOUR TANK DISSOLUTION MODULE (K864635)National Medical Care, Medical Products Div., Inc.1987-01-13
DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM (K862304)Cd Medical, Inc.1986-09-09
MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445 (K861472)National Medical Care, Medical Products Div., Inc.1986-07-10
AMUCHINA/DIALYZER DISINFECTANT (K852359)Amuchina Intl., Inc.1986-05-13
HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS (K860336)Breem Laboratories1986-03-04
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES (K860297)Renal Hygienics1986-03-04
HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES (K860296)Physicians Surgeons Purchasing Group1986-03-04
HEMODIALYSIS CONCENTRATE (K854391)Dana Laboratories1986-01-08
RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT (K852749)Mesa Medical, Inc.1985-09-10
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK (K852310)Erika, Inc.1985-07-26
ALCIDE REN NEW-D (K844734)Alcide Corp.1985-05-17
MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT (K844850)Medicorp, Inc.1985-04-02
FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD (K844750)Seratronics, Inc.1985-02-15
FRESENIUS HAEMODIALYSIS ;MACHINE A1008 (K844641)Seratronics, Inc.1985-02-14
NEPHROSS ALLEGRO H.F. (K844748)Organon Teknika Corp.1985-01-22
ST FAMILY OF HOLLOW FIBER DIALYZERS (K844756)Travenol Laboratories, S.A.1985-01-16
DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD (K843963)Renal Systems, Inc.1985-01-07
UNILYTE A (K843623)Medical Enterprises, Ltd.1984-11-16
HEMODIAL CONCENTRATE MIXING APPARATUS (K842225)Lmf Medical Research & Manufacturing, Inc.1984-10-02
FORMACLEAR- & MULTIPLE (K842131)Rna Medical Corp.1984-09-10
MONOXYCHLOROSENE WAREXIN (K834455)Guardian Chemical1984-07-31
PACKETS FOR THE PREP OF DIALYSATES & (K842154)Organon Teknika Corp.1984-07-31
HEMODIALYSIS BATH CONCENTRATE SOLUTION (K842058)Pharmaceutical Development Systems1984-07-26
DIALYSATE ADDITIVES (K842294)Dialysis Products, Inc.1984-06-28
CONCENTRATE CONDUCTIVITY METER (K841543)Renal Systems, Inc.1984-05-22
RENAPAK CONCENTRATE MIXING SYS. (K840182)Renal Systems, Inc.1984-05-02
CHEMLYTE (K834395)Diachem Laboratories1984-04-20
HEMODIAL CONCENTRATE (K834587)Moana Productions, Inc.1984-04-13
BIOSPAL 2400S (K840812)Hospal Medical Corp.1984-04-02
BIOSPAL 3000S (K840811)Hospal Medical Corp.1984-04-02
HOSPAL MODEL H1210 (K840814)Hospal Medical Corp.1984-04-02
BIOSPAL 1200S (K840813)Hospal Medical Corp.1984-04-02
GAMMA STERIL. CAPILLARY FLOW DIALY-G15 (K832663)Travenol Laboratories, S.A.1983-09-12
GAMMA STERILIZED CAPILLARY FLOW DIALYZ (K831940)Travenol Laboratories, S.A.1983-08-08
BICARBONATE/VARIABLE SODIUM KIT-DM-367 (K830908)Extracorporeal Medical Specialities, Inc.1983-06-08
HEMAFLO BLOOD TUBING SETS (K823092)Cobe Laboratories, Inc.1982-11-22
DISSCAP 080 (K822851)Hospal Medical Corp.1982-10-04
CIDEX*DIALYZER DISINFECTING SOLUTION (K822535)Surgikos, Inc.1982-09-30
HPF 100,200,300 CAPILLARY FLOW DIALYZ (K822485)Erika, Inc.1982-08-30
MODEL 100 BICARBONATE CONDUCTIVITY (K821834)Western Laboratories Corp.1982-07-02
GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL (K820769)Gambro, Inc.1982-04-16
DISSCAP 140 (K820965)Hospal Medical Corp.1982-04-16
DISSCAP 110 (K820966)Hospal Medical Corp.1982-04-16
DIALYSATE CONCENTRATE (K812330)Central Biological Co.1981-09-29
MODEL DM-333 DIALYSIS CONTROL STATION (K811444)Extracorporeal Medical Specialities, Inc.1981-06-23
PORTADIAL CARRY-ON KIDNEY MACHINE (K802297)Alan P. Kendal, Ph.D.1981-05-01
HEMOPHRON (K810612)Renal Devices, Inc.1981-04-29
ALTERNATE STERILIZ. FOR CELLULOSE ACET (K810315)Cordis Corp.1981-03-20
MOD. DM-356 IPS INTERFACE MODULE (K800771)Extracorporeal Medical Specialities, Inc.1980-05-20
DMS 3000 (K792252)Renal Care Corp.1980-03-12
PATIENT AID, MODEL DM-351 (K781176)Extracorporeal Medical Specialities, Inc.1978-09-07
DIALYZING FLUIDE DELIVERY SYSTEM (K780081)Travenol Laboratories, S.A.1978-03-31
HEMODIALYSIS APPARATUS (K772161)Heald Manufacturing, Inc.1978-01-03
PRESSURE MODULE 5M1247 (K771375)Travenol Laboratories, S.A.1977-09-15
BEDSIDE CONSOLES (11-3-910 & 11-3-930) (K760965)Seattle Artificial Kidney Supply Co.1976-12-06

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Every clearance here is in the API, with alerts when new ones post.