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

FJI — Predicate Candidate Screening

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

74 daysmedian FDA review time

295 days90th percentile

131clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K190459	Hemoflow F3 and F4 Dialyzers	Fresenius Medical Care Renal Therapies Group, LLC	2019-08-23	178	0
K122952	NIPRO PUREFLUX-L HEMODIALYZER	Nipro Medical Corporation	2013-12-04	435	0
K043342	POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND M	Gambro Renal Products	2005-05-27	172	0
K010366	DISPOSABLE STORAGE CAP	Molded Products, Inc.	2001-11-28	294	0
K011148	ULTRACONCENTRATOR SYSTEM	Interpore Cross Intl.	2001-06-13	58	0
K002761	FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS	Fresenius Medical Care North America	2000-12-04	90	2
K991908	IDEMSA HEMOPHAN HOLLOW FIBER DIALYZERS	Idemsa	2000-04-17	315	0
K992594	A-15 HEMODIALYZER	Althin Medical AB	1999-09-24	52	0
K992565	A-18 HEMODIALYZER	Althin Medical AB	1999-09-23	52	0
K991512	ASAHI AM-R-SERIES DIALYZERS (MODIFIED), MODEL AM-NR-X	Asahi Medical Co., Ltd.	1999-07-29	90	1
K990159	DYNAMIC HOLLOW FIBER DIALYZER DH-SERIES, MODEL AH 90111	Dynamic Technology Corp.	1999-04-19	90	0
K982337	CUPROPHAN AND HEMOPHAN HOLLOW FIBER DIALYZER	Haidylena Medical Egypt	1998-12-29	176	0
K981253	ULTRACON ULTRAFILTRATOR	Interpore Intl.	1998-12-11	249	0
K980658	PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234	Baxter Healthcare Corp	1998-05-19	89	0
K971710	ULTRACON ULTRAFILTRATOR	Quantic Biomedical, Inc.	1998-02-27	295	0
K970708	CLIRANS T-SERIES HOLLOW FIBER DIALYZERS	Terumo Medical Corp.	1997-12-19	296	0
K973291	DYNAMIC HOLLOW FIBER DIALYZER DC-SERIES	Dynamic Technology Corp.	1997-12-19	108	0
K963933	PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALY	Baxter Healthcare Corp	1997-11-24	419	0
K962309	ALTERNATE ENCAPSULATING RESIN SYSTEM FOR MCA HEMODIALYZERS	Althin Medical AB an Affiliate of Baxter Intl	1996-12-27	193	0
K961039	BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CA	Dayspring Medical, Inc.	1996-09-12	182	0
K961040	BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC	Dayspring Medical, Inc.	1996-06-11	89	0
K961026	BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO	Dayspring Medical, Inc.	1996-06-10	88	0
K944436	COBE CENTRYSYSTEM CS 200 DIALYZER	Cobe Renal Care, Inc.	1996-01-29	504	0
K952343	FOCUA 90R, 90HR, 120R, 120HR, 160R, 160HR HOLLOW FIBER DIALY	National Medical Care, Medical Products Div., Inc.	1995-12-22	217	0
K950602	PORT CAPS (PROTECTIVE CLOSURES FOE REPROCESSED HEMODIALYZERS	Reprocessing Products Corp	1995-11-30	294	0
K945746	GAMBRO LUNDIA 94-500 DIALYZER	Cobe Renal Care, Inc.	1995-09-08	289	0
K945622	MCA(TM) 180 HEMODIALYZER	Althin Medical AB an Affiliate of Baxter Intl	1995-05-25	191	0
K935471	FILTRYZER(TM)	Toray Industries (America), Inc.	1995-05-19	550	2
K945631	155 SCE(TM) HEMODIALYZER	Althin Medical AB an Affiliate of Baxter Intl	1995-05-18	183	0
K945623	MCA(TM) 130 HEMODIALYZER	Althin Medical AB an Affiliate of Baxter Intl	1995-05-18	184	0
K945624	MCA(TM) 160 HEMODIALYZER	Althin Medical AB an Affiliate of Baxter Intl	1995-05-18	184	0
K941708	COBE CENTRYSYSTEM CS500 DIALYZER	C.G.H. Medical, Inc.	1995-05-12	401	0
K940910	FILTRYZER	Toray Industries (America), Inc.	1995-05-04	433	1
K950454	CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALY	Baxter Healthcare Corp	1995-04-27	83	0
K930503	CLIRANS WET PACK HOLLOW FIBER DIALYZER	Terumo Medical Corp.	1995-03-06	763	0
K926372	MCA 200 HEMPDIALYZER	Althin Medical AB an Affiliate of Baxter Intl	1995-02-13	783	0
K926567	BAXTER CA DIALYZER	Baxter Healthcare Corp	1995-01-11	741	0
K926005	FRESENIUS HEMOFLOW, VARIOUS MODELS	Fresenius USA, Inc.	1994-08-23	634	0
K914790	HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R	National Medical Care, Medical Products Div., Inc.	1993-03-05	499	0
K905779	ALDETECT	Pochemco, Inc.	1991-05-23	147	0
K904566	NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER	Cobe Laboratories, Inc.	1990-12-12	64	0
K905228	MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ	Baxter Healthcare Corp	1990-12-10	20	0
K903567	BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.	Organon Teknika Corp.	1990-09-24	48	0
K902481	GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER	Gambro, Inc.	1990-07-27	52	0
K893677	HOLLOW FIBER DIALYZER FOCUS 70H	National Medical Care, Medical Products Div., Inc.	1989-07-24	69	0
K891477	CLIRANS HOLLOW FIBER HEMODIALYZER (WET)	Terumo Medical Corp.	1989-06-09	85	0
K892375	MODIFIED AM-SERIES DIALYZERS	Asahi Medical Co., Ltd.	1989-05-18	48	0
K892374	NEW AM-SERIES DIALYZERS	Asahi Medical Co., Ltd.	1989-05-18	48	0
K892523	GAMBRO ALWALL GFS 11,12,PLUS 12 HOLLOW FIBER DIALY	Gambro, Inc.	1989-05-11	30	0
K884339	TORAY FILTRYZER DIALYZERS	Toray Industries (America), Inc.	1989-03-17	154	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