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

Fujinon, Inc. — Predicate Candidate Screening

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

161 daysmedian FDA review time

342 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K120446	FUJINON/FUJIFILM ULTRASONIC ENDOSCOPE EG-530UR2 AND EG-530UT	Fujinon, Inc.	2012-08-13	181	1
K112391	FUJINON COLONOSCOPES	Fujinon, Inc.	2012-07-26	342	0
K102466	FUJINON EPX-4440HD DIGITAL VIDEO PROCESSOR	Fujinon, Inc.	2011-05-25	268	0
K111243	FUJINON ULTRASONIC PROCESSOR	Fujinon, Inc.	2011-05-16	13	0
K091773	FUJINON STERILE OVERTUBES	Fujinon, Inc.	2009-08-07	52	0
K090116	FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MOD	Fujinon, Inc.	2009-04-22	91	0
K063316	FUJINON MODEL EG-530N TRANS NASAL INSERTION	Fujinon, Inc.	2007-03-16	134	0
K063847	FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR,	Fujinon, Inc.	2007-03-01	64	0
K050907	FUJINON G5 BRONCHOSCOPES, MODELS EB-470S, EB-250S, AND EB-27	Fujinon, Inc.	2005-05-19	38	0
K042043	FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5	Fujinon, Inc.	2004-11-24	118	0
K042076	FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250	Fujinon, Inc.	2004-11-18	108	1
K041903	FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5	Fujinon, Inc.	2004-11-10	119	1
K040048	FUJINON DOUBLE BALLOON ENTEROSCOPY SYSTEM	Fujinon, Inc.	2004-06-07	147	0
K993704	GASTRO-INTESTINAL SYSTEM EN-410WM	Fujinon, Inc.	2000-02-11	101	0
K983561	FUJINON EVL-F VIDEO LAPROSCOPE	Fujinon, Inc.	1998-12-16	64	0
K971528	ENDOSCOPICALLY DELIVERALBE ULTRASOUND POINT PORBE SYSTEM (EN	Fujinon, Inc.	1997-12-12	228	0
K954707	BRONCHOSCOPE	Fujinon, Inc.	1995-11-22	41	0
K933544	FUJINON VIDEO LAPORASCOPE	Fujinon, Inc.	1995-04-27	644	0
K944759	200 SERIES GASTRO-INTESTINAL VIDEO SYSTEM	Fujinon, Inc.	1995-04-11	196	2
K933906	CHOLEDOCHOSCOPE/ENDOSCOPE MODIFICATION	Fujinon, Inc.	1994-07-08	331	0
K930297	FUJINON VIDEO LAPAROSCOPE, MODIFIED	Fujinon, Inc.	1994-03-29	432	0
K932312	FUJINON VIDEO LAPAROSCOPE -- MODIFIED	Fujinon, Inc.	1994-02-16	281	0
K933433	MODIFIED BRONCHOSCOPE AND ACCESSORIES	Fujinon, Inc.	1993-11-01	110	0
K930817	LAPAROSCOPIC LYMPHADENECTOMY	Fujinon, Inc.	1993-07-28	161	0
K925599	FUJINON VIDEO LAPAROSCOPE-ADDITIONAL INTENDED USE	Fujinon, Inc.	1993-07-28	265	0
K931223	FUJINON VIDEO LAPAROSCOPE--THORACOSCOPY	Fujinon, Inc.	1993-07-28	140	0
K926444	FUJINON VIDEO LAPAROSCOPE, MODIFICATION	Fujinon, Inc.	1993-06-25	184	0
K912859	FUJINON EVL-F	Fujinon, Inc.	1992-01-23	210	0
K902197	FUJINON EVL-F (TENTATIVE) AND TROCAR	Fujinon, Inc.	1991-03-05	293	0
K894763	FUJINON EDU SYSTEM	Fujinon, Inc.	1990-05-22	299	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