Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FKP — Predicate Candidate Screening

50 FDA 510(k) clearances under this product code; the 50 most recent screened below.

73 daysmedian FDA review time

272 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K181991	NxStage Connected Health System	Nxstage Medical, Inc.	2018-09-26	62	0
K131739	NXSTAGE CONNECTED HEALTH SYSTEM	Nxstage Medical, Inc.	2013-10-10	119	0
K130460	NXSTAGE DOSING CALCULATOR	Nxstage Medical, Inc.	2013-07-11	139	0
K040074	ONEVIEW INTERFACE	Nxstage Medical, Inc.	2004-04-08	85	0
K021060	FRESENIUS ICARE MONITORING SYSTEM	Fresenius Medical Care North America	2002-11-13	225	0
K003615	STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIP	Environmental Test Systems, Inc.	2001-02-01	71	4
K992255	CKHEMO, MODEL CKHEMO VERSION 1.0	Csam, Inc.	1999-11-30	147	0
K964264	HIGH RANGE PEROXIDE TEST STRIP	Integrated Biomedical Technology, Inc.	1997-06-16	234	0
K955423	PACK H HEMODIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAM	Fresenius USA, Inc.	1996-06-13	198	0
K953854	WATERCHECK REAGENT STRIP FOR CHLORINE & PEROXIDE	Integrated Biomedical Technology, Inc.	1996-03-11	217	0
K930181	BIOPURE DIALYSATE CONCENTRATE MIX SYST/CONCENTRATE	Fresenius USA, Inc.	1995-11-29	1049	0
K922757	SPS 1550 SINGLE NEEDLE PATIENT SYSTEM	Baxter Healthcare Corp	1995-02-13	979	0
K921456	FRESENIUS 3008/FDS-08 DIALYSATE DELIVERY SYSTEM	Fresenius USA, Inc.	1994-04-20	754	3
K910215	DRAKE WILLOCK SYSTEM 1000 DIALYSATE DELIVERY SYST	Cd Medical, Inc.	1991-04-09	82	5
K905793	COBE CENTRY 2 BICART OPTION KIT	Cobe Laboratories, Inc.	1991-02-12	47	0
K905388	COBE CENTRYSYSTEM 3 BICART OPTION KIT	Cobe Laboratories, Inc.	1991-02-11	73	0
K904967	HOSPAL BICART RETROFIT KIT NA/MONIT S GS HEMODIAL	Gambro-Hosp-Cobe, Inc.	1991-01-28	84	0
K896758	GAMBRO BICARBONATE MONITOR BCM 10-3	Gambro, Inc.	1990-09-28	301	0
K896757	GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWS	Gambro, Inc.	1990-08-30	272	0
K894838	HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB	Baxter Healthcare Corp	1989-09-07	38	2
K890824	FRESENIUS 2008 TOUCH PANEL CONTROL DIALYSIS SYSTEM	Fresenius USA, Inc.	1989-05-11	83	0
K883111	HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650	Baxter Healthcare Corp	1989-02-08	198	2
K880459	480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE	Cd Medical, Inc.	1988-04-13	70	0
K873155	GAMBRO BICART SYSTEM	Gambro, Inc.	1987-10-26	77	0
K871218	MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT	Hospal Medical Corp.	1987-04-30	34	0
K863609	SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22	International Medical Products, Inc.	1987-02-25	162	0
K864094	GAMBRO FLUID CONTROL MONITOR FCM 10-1	Gambro, Inc.	1986-11-07	17	0
K864083	GAMBRO BICARBONATE MONITOR BCM 10-2	Gambro, Inc.	1986-11-06	17	0
K861230	MONITRAL S	Hospal Medical Corp.	1986-04-25	24	0
K854479	BEDSIDE CONSOLE HA-57P/BLOOD & HEPARIN PUMP BIP-BH	Nipro Company, Ltd.	1985-12-16	39	0
K854367	HD-SECURA HEMADIALYSIS MACHINE	Organon Teknika Corp.	1985-12-16	48	0
K853513	DRAKE WILLOCK 480 UF CONTROL IDALYSATE DELIVERY SY	Cd Medical, Inc.	1985-11-06	77	0
K851306	COBE SYSTEM 3	Cobe Laboratories, Inc.	1985-06-12	72	0
K850569	BSM 2000 DIALYSIS MACHINE - MODIFIED	Organon Teknika Corp.	1985-03-12	28	0
K850179	MBM(TM) MONITRAL (R) BICARBONATE MODULE	Hospal Medical Corp.	1985-02-28	42	0
K813432	HEMODIALYSIS SYSTEM	Fhk	1982-06-23	197	0
K811972	EXTRASENSR ULTRAFILTRATION MONITOR	Extracorporeal Medical Specialities, Inc.	1981-11-16	129	0
K811591	B-D DRAKE WILLOCK #7000 SERIES ULTRAF	Bd Becton Dickinson Vacutainer Systems Preanalytic	1981-07-10	32	0
K802880	EXTRACORPOREAL'S #DM-952 DIALYSATE BYPAS	Extracorporeal Medical Specialities, Inc.	1980-12-17	30	0
K802250	DIALYSIS CONTROL UNIT-CENTRY 2000	Cobe Laboratories, Inc.	1980-12-10	85	0
K800330	MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM	Bd Becton Dickinson Vacutainer Systems Preanalytic	1980-04-08	55	0
K800425	GAMBRO AK-10-UDM-10-A ULTRADIFFUSION	Gambro, Inc.	1980-04-08	42	0
K792173	MODELS DM-360 & DM-350-L SINGLE PATIENT	Extracorporeal Medical Specialities, Inc.	1979-11-16	18	0
K781886	DIALYSATE DELIVERY SYSTEM	Cordis Corp.	1979-01-17	71	0
K781405	SUITCASE KIDNEY HEMODIALYSIS SYSTEM	Union Carbide Corp.	1978-12-07	115	0
K780682	SINGLE PATIENT SYSTEMS	Extracorporeal Medical Specialities, Inc.	1978-06-22	59	0
K771696	EMODIALYSIS DEL. SYS. MODEL 7110	Bd Becton Dickinson Vacutainer Systems Preanalytic	1977-09-15	9	0
K771065	DYLADE, MODEL DS	Milton Roy Co. Analytical	1977-06-24	11	0
K770350	DIALYSIS DELIVERY SYS., ULTIM. MODEL II	Vital Systems, Inc.	1977-03-08	14	0
K761287	5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY	Travenol Laboratories, S.A.	1977-01-03	14	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda