510(k) Report

510(k) · Cleared

Cleared

Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T

K143556510(k) TraditionalCleared Aug 20, 2015248-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 Medical Systems U.S.A, Inc. · FDA Enteroscope And Accessories

Cleared on Aug 20, 2015 as substantially equivalent to K040048 (Fujinon, Inc., 2004) and 1 other predicate after a 248-day review. Its family tree reaches back 3 generations to 2000. 19 later devices descend from it.

Decided
Aug 20, 2015
Review
248 days
Class
Class II
Product code
FDA
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K993704 (2000). 6 ancestors in all, the oldest K944759 (1995). 19 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1995: 2 other ancestors2021: 3 descendants cleared2019: 3 descendants cleared2017: 1 descendant cleared2023: 2 descendants cleared2024: 3 descendants cleared2015: 1 descendant cleared2026: 3 descendants cleared2025: 3 descendants clearedK993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 2000K040048 · Fujinon Double Balloon Enteroscopy System · Fujinon, Inc. · 2004K090116 · Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 · Fujinon, Inc. · 20091995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants K090116 · Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 · Fujinon, Inc. · 2009K040048 · Fujinon Double Balloon Enteroscopy System · Fujinon, Inc. · 2004K993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 20000
  1. Root · 3 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
  2. 2 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
  3. 1 generation backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
  4. This deviceK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
  5. Descendant · cites it directly · 8 of its ownK162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017
  6. Descendant · cites it directly · 5 of its ownK183032 FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation · 2019
  7. Descendant · 2 generations on · 3 of its ownK240142 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T…Fujifilm Corporation · 2024
  8. Descendant · cites it directly · 2 of its ownK213195 Balloon BS-3Fujifilm Corporation · 2021
  9. Descendant · 2 generations on · 2 of its ownK193123 FUJIFILM Distal Cap Models 33-40Fujifilm Corporation · 2019

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2015: 12017: 12019: 32021: 32023: 22024: 32025: 32026: 3
2015high 3 (2019) · low 0 (2016)2026

Most influential descendants

Showing 5 of 19 · See all
  • K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017 · cites it directly8descendants
  • K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation · 2019 · cites it directly5descendants
  • K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation · 2024 · 2 generations on3descendants
  • K213195Balloon BS-3Fujifilm Corporation · 2021 · cites it directly2descendants
  • K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation · 2019 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K993704Gastro-Intestinal System EN-410WMFujinon, Inc.2000—
−2K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc.2004—
−1K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.2009—
0 (this device)K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.2015—
+1K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.2017—
+1K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation2019—
+2K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM…Fujifilm Corporation2024—
+1K213195Balloon BS-3Fujifilm Corporation2021—
+2K193123FUJIFILM Distal Cap Models 33-40Fujifilm Corporation2019—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201710
201930
202130
202320
202430
202530
202630
FIG. 1 — Lineage of K143556, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260314 Ancora-SBscore 13.4 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*K040048Fujinon Double Balloon Enteroscopy System
Summary page 4
…cope and accessories, 21 CFR § 876.1500, Product Codes: FDA, FDF Predicate Devices  Fujinon, Inc., Double Balloon Enteroscope, Model EN-450P5/20 (K040048)  Fujinon, Inc., Double Balloon Enteroscope, Model EC-450BI5 (K090116) Intended Use / Indications for Use…
Fujinon, Inc.2004—
*K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15
Summary page 4
…Predicate Devices  Fujinon, Inc., Double Balloon Enteroscope, Model EN-450P5/20 (K040048)  Fujinon, Inc., Double Balloon Enteroscope, Model EC-450BI5 (K090116) Intended Use / Indications for Use The Fujifilm Double Balloon Endoscopes, Models EN-530T and EN-580T are intende…
Fujinon, Inc.2009—

Also cleared against K040048: 9 other devices →

What descends from it? (19)

See all 19

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

NumberDeviceApplicantDecidedDescendants
K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.20178
K183032FUJIFILM Double Balloon Endoscope EI580BTFujifilm Corporation20195
K213195Balloon BS-3Fujifilm Corporation20212
K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation20192
K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton20231
K153483Balloon controller PB-30Fujifilm Medical Systems U.S.A, Inc.20151
K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation20240

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 15 years and passes through 2 companies; a new generation was cleared every 4.9 years on median.
  • 3 of the 6 ancestors have a recall of any class.
  • Of its descendants, K162749 (Fujifilm Medical Systems U.S.A, Inc., 2017) has gone furthest, with 8 descendants of its own.
  • 9 other devices also cite its predicate K040048.

How does its category compare?

All FDA devices

FDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · FDA

1in 2025

2008: 12015: 12019: 22020: 12021: 12023: 22024: 12025: 12026 (partial year): 1
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

2007: 12008: 12009: 32010: 12012: 22013: 22014: 32015: 22016: 52017: 282018: 812019: 762020: 292021: 242022: 872023: 722024: 862025: 116
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20081—01
20090—03
20100—01
20110—00
20120—02
20130—02
20140—03
20151—02
20160—05
20170—028
20180—081
20192—076
20201—029
20211—024
20220—087
20232—072
20241—086
20251—0116
20261—0—

What is it indicated for?

The Fujifilm Double Balloon Endoscopes 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.

Indications for use as stated in the FDA summary.

Also cleared against K040048

9 other devices cite the same predicate.

  • K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation · 2019
  • K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
  • K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011
  • K091773Fujinon Sterile OvertubesFujinon, Inc. · 2009
  • K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc. · 2009
  • K060923Naviaid Bge Device, Model 21-001Smart Medical Systems, Ltd. · 2006

More from Fujifilm Medical Systems U.S.A, Inc.

44 FDA decisions under this applicant name. See the company

  • P160031/S004ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) OptionFujifilm Medical Systems U.S.A, Inc. · 2023
  • P160031/S003ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) OptionFujifilm Medical Systems U.S.A, Inc. · 2020
  • P160031/S002Aspire Cristalle Digital Breast Tomosynthesis OptionFujifilm Medical Systems U.S.A, Inc. · 2019
  • P160031/S001ASPIRE Cristalle Breast Tomosynthesis SystemFujifilm Medical Systems U.S.A, Inc. · 2019
  • K171291FUJIFILM Bronchoscope Model EB-530PFujifilm Medical Systems U.S.A, Inc. · 2018

Recent decisions in FDA

The FDA category page

  • K260314Ancora-SBAspero Medical, Inc. · 2026
  • K251204FUJIFILM Stiffening Wire Device (SW-2000)FUJIFILM Healthcare Americas Corporation · 2025
  • K233321Double Balloon Endoscope EN-840T, Over-tube TS-1214CFUJIFILM Healthcare Americas Corporation · 2024
  • K231323Ancora-SBAspero Medical, Inc. · 2023
  • K223295Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500DFujifilm Corporaton · 2023

https://510kreport.com/device/K143556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K143556: Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143556

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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