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

FJG — Predicate Candidate Screening

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

63 daysmedian FDA review time

169 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K933681	GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS	Cobe Renal Care, Inc.	1994-09-07	405
K933680	GAMBRO LUNDIA PRO 200 DIALYZER	Cobe Renal Care, Inc.	1994-08-26	393
K920693	DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9	National Medical Care, Medical Products Div., Inc.	1992-09-21	220
K915504	GAMBRO LUNDIA ALPHA HEMODIALYZERS	C.G.H. Medical, Inc.	1992-03-06	88
K901368	HEMOSPAL KITS A1, A2D, AO, & A1D	Gambro-Hospal, Inc.	1990-08-02	132
K902203	TENCKHOFF PERITONEAL DIALYSIS KIT	Akcess Medical Products, Inc.	1990-08-01	77
K862840	GAMBRO LUNDIA 10-1L, 1N, 1H, 3H, 4N, 4H, 5H, 6N	Gambro, Inc.	1986-09-29	62
K853406	GAMBRO LUNDIA PRO 3 & 5 DIALYZER	Gambro, Inc.	1986-01-08	149
K820694	COBE PPD 1.3L, #18-520-009	Cobe Laboratories, Inc.	1982-03-31	19
K812336	COBE PPD 1.9	Cobe Laboratories, Inc.	1981-08-31	13
K811439	EXP 200 PARALLEL PLATE DIALYZER	Extracorporeal Medical Specialities, Inc.	1981-06-12	21
K811440	EXP 600 PARALLEL PLATE DIALYZER	Extracorporeal Medical Specialities, Inc.	1981-06-12	21
K810066	COBE PPD .8	Cobe Laboratories, Inc.	1981-06-09	147
K810837	CYBER 80 HEMODIALYZER	Cyberex Corp.	1981-05-05	40
K802478	CYBER 120 HEMODIALYZER	Cyberex Corp.	1981-03-20	169
K803068	NIKKISO ND-14 PARALLEL FLOW DIALYZER	NIKKISO CO., LTD.	1981-03-04	90
K802364	EXTRACORPOREAL'S EXP 400 PARALLEL PLATE	Extracorporeal Medical Specialities, Inc.	1981-01-29	122
K802389	GAMBRO LUNDIA PLATE DISP. DIALYZER	Gambro, Inc.	1980-12-22	84
K801633	THE BRAVO NEW PARALLEL FLOW DIALYZER	Bellco Artifidial Organ Spec., Inc.	1980-12-18	156
K801451	ISONEPHROS-PEDIATRIC, STANDARD, OPTIMUM	Medical, Inc.	1980-09-26	95
K801377	CYBER 120 HEMODIALYZER	Cyberex Corp.	1980-08-27	77
K800424	LUNDIA PLATE DISP.	Gambro, Inc.	1980-04-10	44
K792611	GAMBRO LUNDIA PLATE DIALYZER	Gambro, Inc.	1980-02-06	50
K791961	EXTRACORPOREAL'S MODEL EX-85 DIALYZER	Extracorporeal Medical Specialities, Inc.	1979-11-13	43
K791448	HEMODIALYZERS RP-510 AND RP-514	Hospal Medical Corp.	1979-08-07	1
K790758	HEMOCLEAR U-NEPHROS 1.0 DIALYZER	Medical, Inc.	1979-05-08	21
K790533	HD CAPILLARY FILM DIALYZER, MODEL 1001	Travenol Laboratories, S.A.	1979-05-02	48
K790001	DIALYZER, MODEL F.M.D 150	Hospal Medical Corp.	1979-03-06	63
K781966	DIALYZER, MAGNIFLO 100 PARALLEL PLATE	Erika, Inc.	1979-02-21	89
K781795	DIALYZER, PARALLEL FLOW DISPOSABLE	Medical, Inc.	1978-12-15	51
K780700	LUNDIA PLATE DISPOSABLE DIALYZER	Gambro, Inc.	1978-07-17	82
K780427	RP-510/RP-514 PARALLEL PLATE DIALYZERS	Hospal Medical Corp.	1978-05-19	63
K772318	DIALYZER STANDARD, CODE 5DM1780	Travenol Laboratories, S.A.	1978-01-26	38
K771354	PARALLEL PLATE DIALYZERS	Hospal Medical Corp.	1977-09-15	55
K770858	DIALYZER, ULTRADIFFUSER, DISPOSABLE	Gambro, Inc.	1977-06-14	36
K770578	PARALLEL PLATE DIALYZER	Cobe Laboratories, Inc.	1977-04-15	18

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