510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5

K042076510(k) TraditionalCleared Nov 18, 2004108-day reviewClass II21 CFR 876.1500Recalls 4

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

Fujinon, Inc. · FDT Duodenoscope And Accessories, Flexible/Rigid

Cleared on Nov 18, 2004 as substantially equivalent to K944620 (Marks & Murase, 1995) and 1 other predicate after a 108-day review. Its family tree reaches back 1 generation to 1995. 6 later devices descend from it. It has been recalled 4 times.

Decided
Nov 18, 2004
Review
108 days
Class
Class II
Product code
FDT
Recalls
4
Predicates
2

Its longest line of descent runs back 1 generation to K944759 (1995). 2 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2017: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2026: 1 descendant cleared2020: 1 descendant clearedK944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 2 descendants K944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalled0
  1. Root · 1 generation backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
  2. This deviceK042076 Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc. · 2004
  3. Descendant · cites it directly · 5 of its ownK152257 Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. · 2017 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK181745 FUJIFILM Duodenoscope ModelFujifilm Corporation · 2019
  5. Descendant · 3 generations on · 2 of its ownK191747 FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation · 2019
  6. Descendant · 4 generations on · 0 of its ownK251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model…Fujifilm Corporation · 2026
  7. Descendant · 4 generations on · 0 of its ownK203028 FUJIFILM Distal End CapFujifilm Corporation · 2020

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 22020: 12026: 1
2017high 2 (2019) · low 0 (2021)2026

Most influential descendants

Showing 5 of 6 · See all
  • K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc. · 2017 · cites it directly5descendants
  • K181745FUJIFILM Duodenoscope ModelFujifilm Corporation · 2019 · 2 generations on3descendants
  • K191747FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation · 2019 · 3 generations on2descendants
  • K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…Fujifilm Corporation · 2026 · 4 generations on0descendants
  • K203028FUJIFILM Distal End CapFujifilm Corporation · 2020 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944759200 Series Gastro-Intestinal Video SystemFujinon, Inc.19955
0 (this device)K042076Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc.2004—
+1K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc.20173
+2K181745FUJIFILM Duodenoscope ModelFujifilm Corporation2019—
+3K191747FUJIFILM Duodenoscope Model ED-580XTFujifilm Corporation2019—
+4K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP…Fujifilm Corporation2026—
+4K203028FUJIFILM Distal End CapFujifilm Corporation2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201920
202010
202610
FIG. 1 — Lineage of K042076, 1995–2026Source: 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 FDT? 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 FDT device

  1. #1 K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM…score 13.7 · 10 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
*K944620Series 400 Gastroenterology System
Summary page 1
…G5 Duodenoscopes Common Name: Duodenoscopes Classification: Class 11, 21 CFR 876.1500, FAK Predicate Device 121 CFR 807.92(a)(3)J * Fujinon ED-400XL - K944620 * Fujinon ED-200XU - K944759 The G5 changes were described and cleared by FDA in the 510(k) submission for the Fuj…
Marks & Murase19952
*K944759200 Series Gastro-Intestinal Video System
Summary page 1
…oscopes Classification: Class 11, 21 CFR 876.1500, FAK Predicate Device 121 CFR 807.92(a)(3)J * Fujinon ED-400XL - K944620 * Fujinon ED-200XU - K944759 The G5 changes were described and cleared by FDA in the 510(k) submission for the Fujinon Double Bal- loon Enteroscopy Sy…
Fujinon, Inc.19955

Also cleared against K944620: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K152257Fujifilm Duodenoscope Model ED-530XTFujifilm Medical Systems U.S.A, Inc.20175

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

Recalls of this device

DateClassRecallRoot causeReason
Dec 23, 2015Class IIZ-1864-2016OtherThis correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Dec 23, 2015Class IIZ-1863-2016OtherThis correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Dec 23, 2015Class IIZ-1860-2016OtherThis correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Jun 30, 2015Class IIZ-2778-2015Device DesignThe suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

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, K152257 (Fujifilm Medical Systems U.S.A, Inc., 2017) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K944620.

How does its category compare?

All FDT devices

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

FDA decisions per year · FDT

2in 2025

2008: 12009: 12011: 12016: 12017: 22018: 32019: 52020: 42021: 22022: 12024: 22025: 22026 (partial year): 2
2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDT

72in 2020

2018: 63 days median2019: 88 days median2020: 72 days median
2007high 88 (2019) · low 63 (2018)2026

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

Recalls per year · FDT

7so far in 2026, the most since 2007

2015: 12016: 12018: 12021: 12023: 32025: 12026 (partial year): 7
2007high 7 (2026) · low 0 (2007)2026

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

Adverse event reports per year · FDT

3,946in 2025

2007: 42008: 112009: 182010: 122011: 102012: 152013: 182014: 362015: 2462016: 2472017: 7912018: 4812019: 1,3472020: 8222021: 1,2702022: 2,6192023: 3,0502024: 3,0192025: 3,946
2007high 3,946 (2025) · low 4 (2007)2025

MAUDE reports naming product code FDT, 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—04
20081—011
20091—018
20100—012
20111—010
20120—015
20130—018
20140—036
20150—1246
20161—1247
20172—0791
20183631481
201958801,347
20204720822
20212—11,270
20221—02,619
20230—33,050
20242—03,019
20252—13,946
20262—7—

What is it indicated for?

The device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Indications for use as stated in the FDA summary.

Also cleared against K944620

4 other devices cite the same predicate.

  • K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
  • K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
  • K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004
  • K041903Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 20041 recall

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 FDT

The FDT category page

  • K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm Corporation · 2026
  • K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. · 2026
  • K251867Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 20251 recall
  • K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025
  • K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical…Pentax of America, Inc. · 2024

https://510kreport.com/device/K042076 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042076: Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042076

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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