510(k) · Cleared

Cleared

FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5

K183683510(k) SpecialCleared Feb 27, 201961-day reviewClass II21 CFR 876.1500

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

Fujifilm Corporation · FDA Enteroscope And Accessories

Cleared on Feb 27, 2019 as substantially equivalent to K143556 (Fujifilm Medical Systems U.S.A, Inc., 2015) and 2 other predicates after a 61-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.

Decided: Feb 27, 2019
Review: 61 days
Class: Class II
Product code: FDA
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K993704 (2000). 7 ancestors in all, the oldest K944759 (1995). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
3 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
2 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
1 generation backK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
This deviceK183683 FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20…Fujifilm Corporation · 2019
Descendant · cites it directly · 1 of its ownK223295 Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit…Fujifilm Corporaton · 2023
Descendant · 2 generations on · 0 of its ownK233321 Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024

Most influential descendants

Showing 2 of 2 · See all

K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton · 2023 · cites it directly1descendant
K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K993704	Gastro-Intestinal System EN-410WM	Fujinon, Inc.	2000	—
−3	K040048	Fujinon Double Balloon Enteroscopy System	Fujinon, Inc.	2004	—
−2	K090116	Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15	Fujinon, Inc.	2009	—
−1	K143556	Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T	Fujifilm Medical Systems U.S.A, Inc.	2015	—
0 (this device)	K183683	FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5	Fujifilm Corporation	2019	—
+1	K223295	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D	Fujifilm Corporaton	2023	—
+2	K233321	Double Balloon Endoscope EN-840T, Over-tube TS-1214C	FUJIFILM Healthcare Americas Corporation	2024	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2023	1	0
2024	1	0

FIG. 1 — Lineage of K183683, 2000–2024Source: 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 FDA? 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 FDA device

#1 K260314 Ancora-SBscore 13.4 · 8 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? (3)

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
*	K143556	Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T Summary page 4 …Endoscope and accessories, 21 C.F.R. § 876.1500 Product Code: FDA, FDF Predicate Devices: FUJIFILM Double Balloon Endoscope Model EN-580T (K143556) Fujinon EC-450BI5 (K090116) Fujinon EN-450P5/20 (K040048) Intended Use / Indications for Use: EN-580T, EN-450P5/20 and EN-450T…	Fujifilm Medical Systems U.S.A, Inc.	2015	—
*	K090116	Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 Summary page 4 …ssories, 21 C.F.R. § 876.1500 Product Code: FDA, FDF Predicate Devices: FUJIFILM Double Balloon Endoscope Model EN-580T (K143556) Fujinon EC-450BI5 (K090116) Fujinon EN-450P5/20 (K040048) Intended Use / Indications for Use: EN-580T, EN-450P5/20 and EN-450T5 are intended for the visua…	Fujinon, Inc.	2009	—
*	K040048	Fujinon Double Balloon Enteroscopy System Summary page 4 …Product Code: FDA, FDF Predicate Devices: FUJIFILM Double Balloon Endoscope Model EN-580T (K143556) Fujinon EC-450BI5 (K090116) Fujinon EN-450P5/20 (K040048) Intended Use / Indications for Use: EN-580T, EN-450P5/20 and EN-450T5 are intended for the visualization of the upper and lowe…	Fujinon, Inc.	2004	—

Also cleared against K143556: 6 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K223295	Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D	Fujifilm Corporaton	2023	1

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
3 of the 7 ancestors have a recall of any class.
Of its descendants, K223295 (Fujifilm Corporaton, 2023) has gone furthest, with 1 descendant of its own.
6 other devices also cite its predicate K143556.

How does its category compare?

All FDA devices

FDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · FDA

1in 2025

2007high 2 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDA

Too few FDA 510(k)s in any year since 2007 to give a median.

Recalls per year · FDA

No recall names FDA since 2007.

Adverse event reports per year · FDA

116in 2025

2007high 116 (2025) · low 0 (2011)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	1
2008	1	—	1
2009	0	—	3
2010	0	—	1
2011	0	—	0
2012	0	—	2
2013	0	—	2
2014	0	—	3
2015	1	—	2
2016	0	—	5
2017	0	—	28
2018	0	—	81
2019	2	—	76
2020	1	—	29
2021	1	—	24
2022	0	—	87
2023	2	—	72
2024	1	—	86
2025	1	—	116
2026	1	—	—

What is it indicated for?

EN-580T, EN-450P5/20 and EN-450T5 are intended for the visualization of the upper and lower digestive tracts. Specifically, for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, duodenum, small intestine, large intestine, and rectum.

EC-450BI5 is intended for the optical visualization of the gastrointestinal tract. This includes the rectum, large and small intestines. It is intended for observation, diagnosis, and endoscopic treatment.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K183683 · printed Nov 5, 2026

Cite this page

510(k) Report. “K183683: FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183683

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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