510(k) · Cleared

Recalled · 2006

Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5

K041903510(k) TraditionalCleared Nov 10, 2004119-day reviewClass II21 CFR 876.1500Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujinon, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid

Cleared on Nov 10, 2004 as substantially equivalent to K944620 (Marks & Murase, 1995) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 1995. 75 later devices descend from it. It has been recalled once.

Decided: Nov 10, 2004
Review: 119 days
Class: Class II
Product code: FDF
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K944759 (1995). 2 ancestors in all. 75 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
This deviceK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004
Descendant · cites it directly · 45 of its ownK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
Descendant · cites it directly · 33 of its ownK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
Descendant · 2 generations on · 25 of its ownK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
Descendant · 3 generations on · 19 of its ownK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
Descendant · 2 generations on · 19 of its ownK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2009high 9 (2023) · low 0 (2013)2026

Most influential descendants

Showing 5 of 75 · See all

K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc. · 2009 · cites it directly45descendants
K112391Fujinon ColonoscopesFujinon, Inc. · 2012 · cites it directly33descendants
K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014 · 2 generations on25descendants
K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016 · 3 generations on19descendants
K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015 · 2 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K944759	200 Series Gastro-Intestinal Video System	Fujinon, Inc.	1995	5
0 (this device)	K041903	Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5	Fujinon, Inc.	2004	—
+1	K090116	Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15	Fujinon, Inc.	2009	—
+1	K112391	Fujinon Colonoscopes	Fujinon, Inc.	2012	—
+2	K132210	Fujifilm 600 Series Endoscopes	Fujifilm Medical Systems U.S.A, Inc.	2014	—
+3	K160196	Fujifilm Video Colonoscope Model EC-600WL V2	Fujifilm Medical Systems U.S.A, Inc.	2016	—
+2	K143556	Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T	Fujifilm Medical Systems U.S.A, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	3	0
2010	1	0
2011	1	0
2012	4	0
2014	3	0
2015	4	0
2016	7	0
2017	1	0
2018	5	0
2019	8	0
2020	3	0
2021	5	0
2022	2	0
2023	9	0
2024	6	0
2025	5	0
2026	8	0

FIG. 1 — Lineage of K041903, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FDF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new FDF device

#1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K944620	Series 400 Gastroenterology System Summary page 1 …n G5 Colonoscopes Common Name: Colonoscope Classification: Class II, 21 CFR 876.1500, FDF Predicate Device [21 CFR 807.92(a)(3)] * Fujinon EC-400L -- K944620 * Fujinon EC-200LR -- K944759 for…	Marks & Murase	1995	2
*	K944759	200 Series Gastro-Intestinal Video System Summary page 1 …noscope Classification: Class II, 21 CFR 876.1500, FDF Predicate Device [21 CFR 807.92(a)(3)] * Fujinon EC-400L -- K944620 * Fujinon EC-200LR -- K944759 for the Fujinon Double Bal- The G 5 ch…	Fujinon, Inc.	1995	5
†	K040048	Fujinon Double Balloon Enteroscopy System	Fujinon, Inc.	2004	—

Also cleared against K944620: 4 other devices →

What descends from it? (75)

See all 75

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K090116	Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15	Fujinon, Inc.	2009	45
K112391	Fujinon Colonoscopes	Fujinon, Inc.	2012	33

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 27, 2006	Not classified	Z-0708-06	Other	Colonoscope insertion tube is not bending properly and is stiff.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 2 ancestors have a recall of any class.
Of its descendants, K090116 (Fujinon, Inc., 2009) has gone furthest, with 45 descendants of its own.
4 other devices also cite its predicate K944620.

How does its category compare?

All FDF devices

FDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDF

4in 2025

2007high 7 (2012) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDF

194in 2025

2007high 250 (2020) · low 30 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FDF

8in 2023

2007high 8 (2023) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDF

17,231in 2025

2007high 17,231 (2025) · low 48 (2010)2025

MAUDE reports naming product code FDF, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	4	70	0	81
2008	2	—	0	68
2009	6	91	0	83
2010	4	101	0	48
2011	2	—	0	77
2012	7	241	0	88
2013	2	—	0	63
2014	6	164	0	60
2015	2	—	1	100
2016	7	98	1	170
2017	4	36	0	370
2018	7	101	0	388
2019	4	56	0	417
2020	4	250	1	687
2021	3	30	0	2,444
2022	5	147	0	8,345
2023	6	203	8	11,748
2024	2	—	0	12,128
2025	4	194	0	17,231
2026	5	147	0	—

What is it indicated for?

The device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041903 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041903: Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041903

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026