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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 100 of 122 Results
ProductCode: kpo Decision Date To: 12/21/2021
 
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citrasate liquid acid concentrate, naturalyte liquid acid concentrate Fresenius Medical Care Renal Therapies Group, LLC K212620 05/12/2022
hmb32 dialysis solution Haemopharm Biofluids S.r.l. K212052 07/23/2021
nipro dry complete dry acid concentrate for hemodialysis Nipro Renal Solutions USA, Corp. K193155 11/25/2020
citrasate dry acid concentrate, granuflo dry acid concentrate Fresenius Medical Care Renal Therapies Group, LLC K192209 05/08/2020
citrasate liquid acid concentrate, naturalyte liquid acid concentrate Fresenius Medical Care Renal Therapies Group, LLC K192017 04/24/2020
naturalyte dry bicarbonate concentrate (rx-10 bag), naturalyte dry bicarbonate concentrate (rx-12 bag), naturalyte dry bicarbonate concentrate (carton) Fresenius Medical Care Renal Therapies Group, LLC K191474 02/24/2020
isopure dry acid dissolution system Isopure, Corp. K191093 01/22/2020
citricon liquid and powder (acid concentrate acidified with citric acid), aceticon liquid and powder (acid concentrate acidified with acetic acid or na di acetate), bicarbocon liquid and powder (bicarb concentrate), renacon liquid and powder (acetate concentrate with na acetate) Global Scientific Technologies, LLC K180679 12/07/2018
citric complete dry citric acid (45x) Dimesol USA, LLC K171750 03/06/2018
citryte Di-Chem, Inc. K171015 10/13/2017
bibag FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC K162716 05/18/2017
prismasate Baxter Healthcare Corporation K162887 01/06/2017
rockwell medical citrapure acid concetrate ROCKWELL MEDICAL K160847 10/20/2016
hmb32 HAEMOPHARM BIOFLUIDS SRL K150966 12/04/2015
medicalyte(r) bicarbonate powder (36.83x), medicalyte(r) bicarbonate powder (45x), medicalyte(r) bicarbonate powder (35x DIALYSIS MEDICAL SOLUTIONS, LLC K131202 04/03/2014
citrisol acid concentrate DIASOL, INC. K130511 02/10/2014
fresenius dry acid dissolution units FRESENIUS MEDICAL CARE NORTH AMERICA K131611 08/29/2013
2008k@home hemodialysis machine FRESENIUS MEDICAL CARE NORTH AMERICA K124035 07/03/2013
fresenius 2008t hemodialysis machine with bibag system FRESENIUS MEDICAL CARE, NORTH AMERICA K121341 12/06/2012
prismasate dialysis solutions for continuius renal replacement therapy GAMBRO RENAL PRODUCTS K120333 05/25/2012
acds ISOPURE CORP. K120005 03/29/2012
fresenius 2008 hemodiaysis machine with bibag system FRESENIUS MEDICAL CARE, NORTH AMERICA K120017 02/02/2012
solcart b B. BRAUN AVITUM AG K102194 04/25/2011
fresenius 2008t hemodialysis machine model 190573 FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE K101715 12/21/2010
acid concentrate 45x (2.0k, 3.1ca), model 5m8001a, acid concentrate 45x (2.0k, 2.5ca), model 5m8002a BAXTER HEALTHCARE CORP. K090002 08/07/2009
prismasate dialysis solutions for continuous renal replacement therapy GAMBRO RENAL PRODUCTS K072908 02/04/2008
solcart b B. BRAUN MEDIZINTECHNOLOGIE GMBH K072760 01/29/2008
fresenius naturalyte sodium bicarbonate liquid concentrate, model 08-4000-lb FRESENIUS MEDICAL CARE NORTH AMERICA K071387 06/15/2007
fresenius naturalyte liquid acid concentrate, 9000, 6000 and 4000 series FRESENIUS MEDICAL CARE NORTH AMERICA K070177 03/29/2007
rockwell medicaltechnologies, inc. citrapure ROCKWELL MEDICAL TECHNOLOGIES, INC. K062399 11/17/2006
nxstage dialysate preparation module NXSTAGE MEDICAL, INC. K060296 03/31/2006
modification to: nxstage pureflow-b solution NXSTAGE MEDICAL, INC. K053286 12/22/2005
b. braun modified bicarbonate dialysate B. BRAUN MEDICAL, INC. K052393 11/09/2005
modification to: dryac acid concentrate mix for bicarbonate hemodialysis GAMBRO RENAL PRODUCTS K052253 11/02/2005
normocard 25 (sterile bicarbonate renal dialysis concentrate) DIALYSIS SOLUTIONS, INC. K050827 08/22/2005
nxstage dialysate preparation module, model nx0269 NXSTAGE MEDICAL, INC. K043436 03/17/2005
accusol dialysis solution BAXTER HEALTHCARE CORP. K041428 08/27/2004
b. braun bicarbonate dialysate B. BRAUN MEDICAL, INC. K041683 08/27/2004
nxstage pureflow-b solution NXSTAGE MEDICAL, INC. K042045 08/27/2004
b.braun premixed dialysate B. BRAUN MEDICAL, INC. K034066 03/03/2004
nxstage pureflow solution NXSTAGE MEDICAL, INC. K033386 11/26/2003
fresenius naturalyte granuflo dry acid concentrate 10xx series, 24xx series, 30xx series FRESENIUS MEDICAL CARE K030497 05/20/2003
acidified component concentrates for bicarbonate dialysis containing di-acetate ROCKWELL MEDICAL TECHNOLOGIES, INC. K023985 02/28/2003
bicarbonate dialysate concentrate mixer, model 50 gallon & 100 gallon ROCKWELL MEDICAL TECHNOLOGIES, INC. K022521 01/03/2003
dri-sate dry acid concentrate for bicarbonate dialysate ROCKWELL MEDICAL TECHNOLOGIES, INC. K022500 12/23/2002
diasol-additives DIASOL, INC. K020231 10/21/2002
nxstage premixed dialysate NXSTAGE MEDICAL, INC. K022913 10/21/2002
diasol-bicarb DIASOL, INC. K020230 04/23/2002
nxstage dialysate concentrate, model rfc-100 NXSTAGE MEDICAL, INC. K013655 02/04/2002
hemo-lyte hemodialysis grade sodium bicarbonate powder DI-CHEM, INC. K012328 01/18/2002
hemo-lyte hemodialysis grade sodium bicarbonate solution DI-CHEM, INC. K012547 01/18/2002
prismasate GAMBRO RENAL PRODUCTS K013448 01/15/2002
bicart GAMBRO RENAL PRODUCTS K013724 01/08/2002
dry ac acid concentrate mix for bicarbonate hemodialysis GAMBRO RENAL PRODUCTS K011368 08/02/2001
art bicarbonate for hemodialysis, art bicarbonate liquid for hemodialysis ADVANCED RENAL TECHNOLOGIES, INC. K010760 06/11/2001
normocarb sterile bicarbonate renal dialysis NOVEX PHARMA K001059 06/30/2000
citrasate dialysate acid concentrate liquid, models cs-1xxx-xx, cs-xxx-xx, cs-3xxx-xx ADVANCED RENAL TECHNOLOGIES, INC. K000792 06/08/2000
pure water, inc.'s bicarb mix, storage and distribution system PURE WATER, INC. K993272 04/10/2000
pure water inc's acidified storage and distribution system with optional remote fill PURE WATER, INC. K993058 01/24/2000
dryasol acid concentrate mix DIASOL, INC. K993212 10/22/1999
dri-sate mixer for preparation of acidified dialysate concentrate ROCKWELL MEDICAL TECHNOLOGIES, INC. K983618 08/05/1999
acid concentrate and powder, acetate concentrate liquid and powder, and bicarbonate concentrate liquid and powder ALTHIN BIOPHARM, INC. K990507 05/07/1999
althin medical ab altracart ii ALTHIN MEDICAL AB K990010 04/15/1999
naturalyte, model # 08-4004-1 KAYBATH, INC. K982813 11/06/1998
hemsol-acid concentrate liquid hemogran acid concentrate powder, nephrosol-acetate concentrate powder, bicarbosol-bicare SOLUTION TECHNOLOGIES K982378 08/26/1998
rockwell medical supply, llc. dri-sate acid concentrate mixes INTERNATIONAL MEDICAL PRODUCTS, INC. K981003 06/16/1998
dryalysate concentrate ADVANCED RENAL TECHNOLOGIES, INC. K980659 06/11/1998
dialysol-acid concentrate liquid, granusol-acid concentrate powder, renalsol-acetate concentrate liquid & powder, biosol SOLUTION TECHNOLOGIES K981043 05/26/1998
g.e.m. water systems, international G.E.M. WATER SYSTEMS K970674 11/19/1997
rockwell medical supply, llc. concentrate solutions for acetate dialysate INTERNATIONAL MEDICAL PRODUCTS, INC. K973253 10/30/1997
rockwell medical supply,llc. bicarbonate solution concentrates for bicarbonate dialysis INTERNATIONAL MEDICAL PRODUCTS, INC. K971053 06/16/1997
rockwell medical supply llc hemodialysis concentrate solutions & powders ROCKWELL MEDICAL SUPPLY K954527 03/01/1996
fresenius dialysate acid concentrate FRESENIUS USA, INC. K922088 10/17/1994
western dialysis hemodialysis concentrate WESTERN DIALYSIS SUPPLIES LTD. K941958 09/30/1994
hemodialysis bath MEDI-TECH, INC. K922990 09/12/1994
granulyte dialysate concentrate FRESENIUS USA, INC. K922005 03/30/1994
gambro bicart 720g C.G.H. MEDICAL, INC. K940601 03/22/1994
granulyte powder dialysate concentrate and mixing FRESENIUS USA, INC. K911459 07/17/1991
acetate-free dialyslate solution PHYSIO, INC. K903835 07/05/1991
acid concentrate solutions BIOPHARM, INC. K910319 04/24/1991
premixed dialysate for hemodiafiltration BAXTER HEALTHCARE CORP. K910270 04/18/1991
haemodialysis concentrate BDH, INC. K904946 04/09/1991
acetate concentrates for hemodialysis MEDICAL COMPONENTS, INC. K905021 03/15/1991
gc-01 through gc-99 acetate concentrate GRANITE CHEMICAL CO., INC. K901473 07/27/1990
gc-1000 through gc-3005 acid concentrate GRANITE CHEMICAL CO., INC. K901471 07/27/1990
gc-bc-01, gc-bc-02, gc-bc-03 bicarbonate dry packs GRANITE CHEMICAL CO., INC. K901472 07/27/1990
hemodialysis concentrates and related products P & A CO. K893991 01/11/1990
fresenius biocarb hemodialysis grade sodium bicarb FRESENIUS USA, INC. K896111 12/27/1989
biasol liquid concentrates, add'l acid concentrate BAXTER HEALTHCARE CORP. K895199 12/13/1989
bicarbonate concentrate powder HAEMOLYTE, INC. K891921 04/17/1989
sodium bicarbonate, u.s.p. WILLIAMS MEDICAL CO. K891159 04/07/1989
biasol powder concentrates for bicarb. dialysis BAXTER HEALTHCARE CORP. K884725 01/30/1989
hemodialysis concentrates DOVE MEDICAL SUPPLIES K883068 12/22/1988
biasol concentrates for bicarbonate dialysis BAXTER HEALTHCARE CORP. K880102 05/26/1988
hospal dialysate for c.a.v.h.d. DELMED, INC. K872857 10/05/1987
hemodialysis concentrates & related products INVENTORY SUPPLY CORP. K870979 06/03/1987
powdered bicarbonate concentrate BICARBOLYTE CORP. K865078 03/27/1987
hemodialysis bath concentrate solutions for hemodi DIAL MEDICAL OF FLORIDA, INC. K864265 03/17/1987
bicarbonate mixing system MORRIS TOOL LTD. K864942 03/10/1987
sodium bicarbonate powder/bicarbonate hemodialysis AMERICAN HEALTHCARE CORP. K863631 10/16/1986
 
 
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