510(k) Report

510(k) · Cleared

Cleared

Fujinon Double Balloon Enteroscopy System

K040048510(k) TraditionalCleared Jun 7, 2004147-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

Fujinon, Inc. · FDA Enteroscope And Accessories

Cleared on Jun 7, 2004 as substantially equivalent to K993704 (Fujinon, Inc., 2000) after a 147-day review. Its family tree reaches back 1 generation to 2000. 64 later devices descend from it.

Decided
Jun 7, 2004
Review
147 days
Class
Class II
Product code
FDA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993704 (2000). 64 later devices descend from it, 10 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2009: 5 descendants cleared2006: 3 descendants cleared2011: 3 descendants cleared2015: 3 descendants cleared2012: 4 descendants cleared2019: 4 descendants cleared2008: 3 descendants cleared2016: 5 descendants cleared2010: 2 descendants cleared2014: 2 descendants cleared2021: 4 descendants cleared2017: 1 descendant cleared2023: 4 descendants cleared2024: 4 descendants cleared2013: 2 descendants cleared2020: 2 descendants cleared2026: 5 descendants cleared2018: 2 descendants cleared2022: 1 descendant cleared2025: 3 descendants clearedK993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 10 descendants2 generations forward: 20 descendants3 generations forward: 22 descendants4 generations forward: 11 descendants5 generations forward: 1 descendant K993704 · Gastro-Intestinal System EN-410WM · Fujinon, Inc. · 20000+5
  1. Root · 1 generation backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
  2. This deviceK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
  3. Descendant · cites it directly · 45 of its ownK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
  4. Descendant · cites it directly · 19 of its ownK143556 Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015
  5. Descendant · cites it directly · 18 of its ownK052084 Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005
  6. Descendant · 2 generations on · 8 of its ownK162749 FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017
  7. Descendant · 2 generations on · 7 of its ownK162428 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2005: 22006: 32008: 32009: 52010: 22011: 32012: 42013: 22014: 22015: 32016: 52017: 12018: 22019: 42020: 22021: 42022: 12023: 42024: 42025: 32026: 5
2005high 5 (2009) · low 0 (2007)2026

Most influential descendants

Showing 5 of 64 · See all
  • K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc. · 2009 · cites it directly45descendants
  • K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc. · 2015 · cites it directly19descendants
  • K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc. · 2005 · cites it directly18descendants
  • K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc. · 2017 · 2 generations on8descendants
  • K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016 · 2 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993704Gastro-Intestinal System EN-410WMFujinon, Inc.2000—
0 (this device)K040048Fujinon Double Balloon Enteroscopy SystemFujinon, Inc.2004—
+1K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.2009—
+1K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.2015—
+1K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.2005—
+2K162749FUJIFILM Hood Models DH-28GR, DH-29CR and DH-30CRFujifilm Medical Systems U.S.A, Inc.2017—
+2K162428DiLumen Endolumenal Interventional PlatformLumendi, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200630
200830
200950
201020
201130
201240
201320
201420
201530
201650
201710
201820
201940
202020
202140
202210
202340
202440
202530
202650
FIG. 1 — Lineage of K040048, 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
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What was it cleared against? (1)

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
*K993704Gastro-Intestinal System EN-410WM
Summary page 1
…System Common Name: Enteroscope Classification: Class 11, 21 CFR 876.1500, FDA Predicate Device [21 CFR 807.92(a)(3)] Fujinon Enteroscope EN-41OWM - K993704 The subject device have the same indications for use, material composition, viewing direction, image size, bending, reproce…
Fujinon, Inc.2000—

What descends from it? (64)

See all 64

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

NumberDeviceApplicantDecidedDescendants
K090116Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15Fujinon, Inc.200945
K143556Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580TFujifilm Medical Systems U.S.A, Inc.201519
K052084Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.200518
K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh20126
K060235Endo-Ease Endoscopic OvertubeSpirus Medical, Inc.20065
K051551Small Intestinal Videoscope SystemOlympus Medical Systems Corporation20054
K183683FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5Fujifilm Corporation20192
K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd.20112
K060923Naviaid Bge Device, Model 21-001Smart Medical Systems, Ltd.20062
K091773Fujinon Sterile OvertubesFujinon, Inc.20090

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?

  • Its one ancestor has no recall.
  • Of its descendants, K090116 (Fujinon, Inc., 2009) has gone furthest, with 45 descendants of its own.

How does its category compare?

All FDA devices

FDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

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 device is intended for the Optical visualization of the upper gastrointestinal tract. This includes the esophagus, stomach, duodenum, and small bowel. It is intended for the observation, diagnosis, and endoscopic treatment.

Indications for use as stated in the FDA summary.

More from Fujinon, Inc.

30 FDA decisions under this applicant name. See the company

  • K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 20121 recall
  • K112391Fujinon ColonoscopesFujinon, Inc. · 2012
  • K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
  • K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
  • K091773Fujinon Sterile OvertubesFujinon, Inc. · 2009

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/K040048 · printed Nov 5, 2026

Cite this page

510(k) Report. “K040048: Fujinon Double Balloon Enteroscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040048

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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