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

FKQ — Predicate Candidate Screening

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

54 daysmedian FDA review time

164 days90th percentile

61clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K052764	DIACAP ULTRA DIALYSIS FLUID FILTER	B. Braun Medizintechnologie GmbH	2006-06-09	252	1
K893612	TWO TANK DISSOLUTION MODULE	National Medical Care, Medical Products Div., Inc.	1989-07-24	75	0
K874084	MULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDM	National Medical Care, Medical Products Div., Inc.	1988-04-27	203	0
K873421	KAWASUMI A.V. FISTULA SET	Kawasumi Laboratories Co., Ltd.	1987-10-09	45	0
K870889	ACID FUCHSIN SOLUTIONS	D.R.G. Scientific Industries	1987-07-08	125	0
K861730	ACTRIL FOR KIDNEY MACHINE DISINFECTANT	Renal Systems, Inc.	1987-06-09	399	0
K864635	FOUR TANK DISSOLUTION MODULE	National Medical Care, Medical Products Div., Inc.	1987-01-13	49	0
K862304	DRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEM	Cd Medical, Inc.	1986-09-09	84	0
K861472	MAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445	National Medical Care, Medical Products Div., Inc.	1986-07-10	79	0
K852359	AMUCHINA/DIALYZER DISINFECTANT	Amuchina Intl., Inc.	1986-05-13	343	0
K860336	HEMODIALYSIS CONCENTRATES AND RELATED PRODUCTS	Breem Laboratories	1986-03-04	34	0
K860297	HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES	Renal Hygienics	1986-03-04	35	0
K860296	HEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVES	Physicians Surgeons Purchasing Group	1986-03-04	35	0
K854391	HEMODIALYSIS CONCENTRATE	Dana Laboratories	1986-01-08	69	0
K852749	RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT	Mesa Medical, Inc.	1985-09-10	75	0
K852310	NATURALYTE BICARBONATE CONCENTRATE-DRY PACK	Erika, Inc.	1985-07-26	58	0
K844734	ALCIDE REN NEW-D	Alcide Corp.	1985-05-17	164	0
K844850	MEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENT	Medicorp, Inc.	1985-04-02	110	0
K844750	FRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MOD	Seratronics, Inc.	1985-02-15	71	0
K844641	FRESENIUS HAEMODIALYSIS ;MACHINE A1008	Seratronics, Inc.	1985-02-14	78	0
K844748	NEPHROSS ALLEGRO H.F.	Organon Teknika Corp.	1985-01-22	47	0
K844756	ST FAMILY OF HOLLOW FIBER DIALYZERS	Travenol Laboratories, S.A.	1985-01-16	42	0
K843963	DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD	Renal Systems, Inc.	1985-01-07	88	0
K843623	UNILYTE A	Medical Enterprises, Ltd.	1984-11-16	87	0
K842225	HEMODIAL CONCENTRATE MIXING APPARATUS	Lmf Medical Research & Manufacturing, Inc.	1984-10-02	119	0
K842131	FORMACLEAR- & MULTIPLE	Rna Medical Corp.	1984-09-10	103	0
K834455	MONOXYCHLOROSENE WAREXIN	Guardian Chemical	1984-07-31	225	0
K842154	PACKETS FOR THE PREP OF DIALYSATES &	Organon Teknika Corp.	1984-07-31	62	0
K842058	HEMODIALYSIS BATH CONCENTRATE SOLUTION	Pharmaceutical Development Systems	1984-07-26	65	0
K842294	DIALYSATE ADDITIVES	Dialysis Products, Inc.	1984-06-28	17	0
K841543	CONCENTRATE CONDUCTIVITY METER	Renal Systems, Inc.	1984-05-22	36	0
K840182	RENAPAK CONCENTRATE MIXING SYS.	Renal Systems, Inc.	1984-05-02	106	0
K834395	CHEMLYTE	Diachem Laboratories	1984-04-20	128	0
K834587	HEMODIAL CONCENTRATE	Moana Productions, Inc.	1984-04-13	106	0
K840812	BIOSPAL 2400S	Hospal Medical Corp.	1984-04-02	41	0
K840811	BIOSPAL 3000S	Hospal Medical Corp.	1984-04-02	41	0
K840814	HOSPAL MODEL H1210	Hospal Medical Corp.	1984-04-02	45	0
K840813	BIOSPAL 1200S	Hospal Medical Corp.	1984-04-02	45	0
K832663	GAMMA STERIL. CAPILLARY FLOW DIALY-G15	Travenol Laboratories, S.A.	1983-09-12	35	0
K831940	GAMMA STERILIZED CAPILLARY FLOW DIALYZ	Travenol Laboratories, S.A.	1983-08-08	53	0
K830908	BICARBONATE/VARIABLE SODIUM KIT-DM-367	Extracorporeal Medical Specialities, Inc.	1983-06-08	79	0
K823092	HEMAFLO BLOOD TUBING SETS	Cobe Laboratories, Inc.	1982-11-22	33	0
K822851	DISSCAP 080	Hospal Medical Corp.	1982-10-04	10	0
K822535	CIDEX*DIALYZER DISINFECTING SOLUTION	Surgikos, Inc.	1982-09-30	37	0
K822485	HPF 100,200,300 CAPILLARY FLOW DIALYZ	Erika, Inc.	1982-08-30	13	0
K821834	MODEL 100 BICARBONATE CONDUCTIVITY	Western Laboratories Corp.	1982-07-02	10	0
K820769	GAMBRO LUNDIA 10 3N PARALLEL FLOW DIAL	Gambro, Inc.	1982-04-16	25	0
K820965	DISSCAP 140	Hospal Medical Corp.	1982-04-16	10	0
K820966	DISSCAP 110	Hospal Medical Corp.	1982-04-16	10	0
K812330	DIALYSATE CONCENTRATE	Central Biological Co.	1981-09-29	42	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