Panels › Gastroenterology, Urology › Product code KPO · Class 2
Dialysate Concentrate For Hemodialysis (Liquid Or Powder)
Regulation 876.5820
2510(k)s in 12 months (124 all time)
15recalls in 12 months (113 all time)
113recalls that name a 510(k)
Top companies in KPO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2002 | K022913 | NXSTAGE PREMIXED DIALYSATE Nxstage Medical, Inc. | KPO |
| Oct 21, 2002 | K020231 | DIASOL-ADDITIVES Diasol, Inc. | KPO |
| Apr 23, 2002 | K020230 | DIASOL-BICARB Diasol, Inc. | KPO |
| Feb 4, 2002 | K013655 | NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100 Nxstage Medical, Inc. | KPO |
| Jan 18, 2002 | K012547 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE SOLUTION Di-Chem, Inc. | KPO |
| Jan 18, 2002 | K012328 | HEMO-LYTE HEMODIALYSIS GRADE SODIUM BICARBONATE POWDER Di-Chem, Inc. | KPO |
| Jan 15, 2002 | K013448 | PRISMASATE Gambro Renal Products | KPO |
| Jan 8, 2002 | K013724 | BICART Gambro Renal Products | KPO |
| Aug 2, 2001 | K011368 | DRY AC ACID CONCENTRATE MIX FOR BICARBONATE HEMODIALYSIS Gambro Renal Products | KPO |
| Jun 11, 2001 | K010760 | ART BICARBONATE FOR HEMODIALYSIS, ART BICARBONATE LIQUID FOR HEMODIALYSIS Advanced Renal Technologies, Inc. | KPO |
| Jun 30, 2000 | K001059 | NORMOCARB STERILE BICARBONATE RENAL DIALYSIS Novex Pharma, CA | KPO |
| Jun 8, 2000 | K000792 | CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XX Advanced Renal Technologies, Inc. | KPO |
| Oct 22, 1999 | K993212 | DRYASOL ACID CONCENTRATE MIX Diasol, Inc. | KPO |
| Aug 5, 1999 | K983618 | DRI-SATE MIXER FOR PREPARATION OF ACIDIFIED DIALYSATE CONCENTRATE Rockwell Medical Technologies, Inc. | KPO |
| May 7, 1999 | K990507 | ACID CONCENTRATE AND POWDER, ACETATE CONCENTRATE LIQUID AND POWDER, AND BICARBONATE CONCENTRATE LIQUID AND POWDER Althin Biopharm, Inc., CA | KPO |
| Apr 15, 1999 | K990010 | ALTHIN MEDICAL AB ALTRACART II Althin Medical AB, SE | KPO |
| Nov 6, 1998 | K982813 | NATURALYTE, MODEL # 08-4004-1 Kaybath, Inc. | KPO |
| Aug 26, 1998 | K982378 | HEMSOL-ACID CONCENTRATE LIQUID HEMOGRAN ACID CONCENTRATE POWDER, NEPHROSOL-ACETATE CONCENTRATE POWDER, BICARBOSOL-BICARE Solution Technologies | KPO |
| Jun 16, 1998 | K981003 | ROCKWELL MEDICAL SUPPLY, LLC. DRI-SATE ACID CONCENTRATE MIXES International Medical Products, Inc. | KPO |
| Jun 11, 1998 | K980659 | DRYALYSATE CONCENTRATE Advanced Renal Technologies, Inc. | KPO |
| May 26, 1998 | K981043 | DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOL Solution Technologies | KPO |
| Oct 30, 1997 | K973253 | ROCKWELL MEDICAL SUPPLY, LLC. CONCENTRATE SOLUTIONS FOR ACETATE DIALYSATE International Medical Products, Inc. | KPO |
| Jun 16, 1997 | K971053 | ROCKWELL MEDICAL SUPPLY,LLC. BICARBONATE SOLUTION CONCENTRATES FOR BICARBONATE DIALYSIS International Medical Products, Inc. | KPO |
| Mar 1, 1996 | K954527 | ROCKWELL MEDICAL SUPPLY LLC HEMODIALYSIS CONCENTRATE SOLUTIONS & POWDERS Rockwell Medical Supply | KPO |
| Oct 17, 1994 | K922088 | FRESENIUS DIALYSATE ACID CONCENTRATE Fresenius USA, Inc. | KPO |
| Sep 30, 1994 | K941958 | WESTERN DIALYSIS HEMODIALYSIS CONCENTRATE Western Dialysis Supplies , Ltd., CA | KPO |
| Sep 12, 1994 | K922990 | HEMODIALYSIS BATH Medi-Tech, Inc. | KPO |
| Mar 30, 1994 | K922005 | GRANULYTE DIALYSATE CONCENTRATE Fresenius USA, Inc. | KPO |
| Mar 22, 1994 | K940601 | GAMBRO BICART 720G C.G.H. Medical, Inc. | KPO |
| Jul 17, 1991 | K911459 | GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING Fresenius USA, Inc. | KPO |
| Jul 5, 1991 | K903835 | ACETATE-FREE DIALYSLATE SOLUTION Physio, Inc. | KPO |
| Apr 24, 1991 | K910319 | ACID CONCENTRATE SOLUTIONS Biopharm, Inc. | KPO |
| Apr 18, 1991 | K910270 | PREMIXED DIALYSATE FOR HEMODIAFILTRATION Baxter Healthcare Corp | KPO |
| Apr 9, 1991 | K904946 | HAEMODIALYSIS CONCENTRATE Bdh, Inc., CA | KPO |
| Mar 15, 1991 | K905021 | ACETATE CONCENTRATES FOR HEMODIALYSIS Medical Components, Inc. | KPO |
| Jul 27, 1990 | K901473 | GC-01 THROUGH GC-99 ACETATE CONCENTRATE Granite Chemical Co., Inc. | KPO |
| Jul 27, 1990 | K901472 | GC-BC-01, GC-BC-02, GC-BC-03 BICARBONATE DRY PACKS Granite Chemical Co., Inc. | KPO |
| Jul 27, 1990 | K901471 | GC-1000 THROUGH GC-3005 ACID CONCENTRATE Granite Chemical Co., Inc. | KPO |
| Jan 11, 1990 | K893991 | HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS P & A Co. | KPO |
| Dec 27, 1989 | K896111 | FRESENIUS BIOCARB HEMODIALYSIS GRADE SODIUM BICARB Fresenius USA, Inc. | KPO |
| Dec 13, 1989 | K895199 | BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE Baxter Healthcare Corp | KPO |
| Apr 17, 1989 | K891921 | BICARBONATE CONCENTRATE POWDER Haemolyte, Inc. | KPO |
| Apr 7, 1989 | K891159 | SODIUM BICARBONATE, U.S.P. Williams Medical Co. | KPO |
| Jan 30, 1989 | K884725 | BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS Baxter Healthcare Corp | KPO |
| Dec 22, 1988 | K883068 | HEMODIALYSIS CONCENTRATES Dove Medical Supplies | KPO |
| May 26, 1988 | K880102 | BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS Baxter Healthcare Corp | KPO |
| Oct 5, 1987 | K872857 | HOSPAL DIALYSATE FOR C.A.V.H.D. Delmed, Inc. | KPO |
| Jun 3, 1987 | K870979 | HEMODIALYSIS CONCENTRATES & RELATED PRODUCTS Inventory Supply Corp. | KPO |
| Mar 27, 1987 | K865078 | POWDERED BICARBONATE CONCENTRATE Bicarbolyte Corp. | KPO |
| Mar 17, 1987 | K864265 | HEMODIALYSIS BATH CONCENTRATE SOLUTIONS FOR HEMODI Dial Medical of Florida, Inc. | KPO |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.