510(k) · Cleared

Recalled · Class II · 2015

200 Series Gastro-Intestinal Video System

K944759510(k) TraditionalCleared Apr 11, 1995196-day reviewClass II21 CFR 876.1500Recalls 5

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

Fujinon, Inc. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Cleared on Apr 11, 1995 after a 196-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 91 later devices descend from it. It has been recalled 5 times.

Decided: Apr 11, 1995
Review: 196 days
Class: Class II
Product code: FET
Recalls: 5
Predicates: 0

91 later devices descend from it, 4 citing it directly.

This deviceK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995
Descendant · cites it directly · 75 of its ownK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
Descendant · 2 generations on · 45 of its ownK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
Descendant · cites it directly · 39 of its ownK042043 Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004
Descendant · 2 generations on · 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

Showing 5 of 91 descendants. See all descendants

Descendants cleared per year

1997high 11 (2019) · low 0 (1998)2026

Most influential descendants

Showing 5 of 91 · See all

K041903Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · cites it directly75descendants
K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc. · 2009 · 2 generations on45descendants
K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004 · cites it directly39descendants
K112391Fujinon ColonoscopesFujinon, Inc. · 2012 · 2 generations on33descendants
K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014 · 2 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K944759	200 Series Gastro-Intestinal Video System	Fujinon, Inc.	1995	—
+1	K041903	Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5	Fujinon, Inc.	2004	1
+2	K090116	Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15	Fujinon, Inc.	2009	—
+1	K042043	Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5	Fujinon, Inc.	2004	—
+2	K112391	Fujinon Colonoscopes	Fujinon, Inc.	2012	—
+2	K132210	Fujifilm 600 Series Endoscopes	Fujifilm Medical Systems U.S.A, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2004	3	0
2007	1	0
2009	3	0
2010	1	0
2011	1	0
2012	4	0
2014	3	0
2015	4	0
2016	7	0
2017	2	0
2018	6	0
2019	11	0
2020	4	0
2021	5	0
2022	3	0
2023	9	0
2024	6	0
2025	7	0
2026	10	0

FIG. 1 — Lineage of K944759, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in FET? 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 FET device

#1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (91)

See all 91

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

Number	Device	Applicant	Decided	Descendants
K041903	Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5	Fujinon, Inc.	2004	75
K042043	Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5	Fujinon, Inc.	2004	39
K042076	Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5	Fujinon, Inc.	2004	6
K964131	Endoscope	Akos Biomedical, Inc.	1997	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 23, 2015	Class II	Z-1862-2016	Other	This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Dec 23, 2015	Class II	Z-1861-2016	Other	This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Aug 31, 2015	Class II	Z-0418-2016	Device Design	A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Jun 30, 2015	Class II	Z-2805-2015	Device Design	The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with…
Jun 30, 2015	Class II	Z-2806-2015	Device Design	The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT endoscope is used with…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K041903 (Fujinon, Inc., 2004) has gone furthest, with 75 descendants of its own.

How does its category compare?

All FET devices

FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FET

6in 2025

2007high 6 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FET

166in 2025

2007high 166 (2025) · low 25 (2019)2026

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

Recalls per year · FET

1in 2024

2007high 2 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FET

14,530in 2025

2007high 14,530 (2025) · low 1 (2008)2025

MAUDE reports naming product code FET, 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	1	—	0	2
2008	2	—	0	1
2009	2	—	0	6
2010	1	—	0	3
2011	2	—	0	7
2012	2	—	0	11
2013	2	—	0	8
2014	0	—	0	3
2015	2	—	0	3
2016	1	—	0	25
2017	3	119	0	66
2018	3	98	0	67
2019	3	25	0	72
2020	5	106	0	3,043
2021	1	—	0	5,300
2022	2	—	0	6,156
2023	1	—	2	8,199
2024	2	—	1	13,153
2025	6	166	0	14,530
2026	3	69	0	—

https://510kreport.com/device/K944759 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944759: 200 Series Gastro-Intestinal Video System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944759

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026