510(k) Report

510(k) · Cleared

Cleared

Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5

K042043510(k) TraditionalCleared Nov 24, 2004118-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. · FDS Gastroscope And Accessories, Flexible/Rigid

Cleared on Nov 24, 2004 as substantially equivalent to K944620 (Marks & Murase, 1995) and 1 other predicate after a 118-day review. Its family tree reaches back 1 generation to 1995. 39 later devices descend from it.

Decided
Nov 24, 2004
Review
118 days
Class
Class II
Product code
FDS
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K944759 (1995). 2 ancestors in all. 39 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor2014: 1 descendant cleared2007: 1 descendant cleared2015: 2 descendants cleared2022: 2 descendants cleared2019: 5 descendants cleared2016: 2 descendants cleared2018: 3 descendants cleared2021: 1 descendant cleared2023: 5 descendants cleared2020: 2 descendants cleared2025: 6 descendants cleared2024: 4 descendants cleared2026: 5 descendants 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: 3 descendants2 generations forward: 8 descendants3 generations forward: 17 descendants4 generations forward: 10 descendants5 generations forward: 1 descendant K944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalled0+5
  1. Root · 1 generation backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
  2. This deviceK042043 Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004
  3. Descendant · cites it directly · 25 of its ownK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
  4. Descendant · 2 generations on · 19 of its ownK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
  5. Descendant · 2 generations on · 18 of its ownK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
  6. Descendant · cites it directly · 10 of its ownK063316 Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc. · 2007
  7. Descendant · cites it directly · 6 of its ownK142629 EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015

Showing 5 of 39 descendants. See all descendants

Descendants cleared per year

2007: 12014: 12015: 22016: 22018: 32019: 52020: 22021: 12022: 22023: 52024: 42025: 62026: 5
2007high 6 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 39 · See all
  • K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014 · cites it directly25descendants
  • K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016 · 2 generations on19descendants
  • K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Fujifilm Corporation · 2018 · 2 generations on18descendants
  • K063316Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc. · 2007 · cites it directly10descendants
  • K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015 · cites it directly6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K944759200 Series Gastro-Intestinal Video SystemFujinon, Inc.19955
0 (this device)K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc.2004—
+1K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.2014—
+2K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc.2016—
+2K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and…Fujifilm Corporation2018—
+1K063316Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc.2007—
+1K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201410
201520
201620
201830
201950
202020
202110
202220
202350
202440
202560
202650
FIG. 1 — Lineage of K042043, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FDS? 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 FDS device

  1. #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.4 · 12 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
…non G5 Gastroscopes Common Name: Gastroscope Classification: Class 11, 21 CFR 876.1 500, FDS Predicate Device [21 CFR 807.92(a)(3)J * Fujinon EG-400HR -K944620 * Fujinon EG-200FP - K944759 The 05 changes were described and cleared by FDA in the 5 10(k) submission for the Fuj…
Marks & Murase19952
*K944759200 Series Gastro-Intestinal Video System
Summary page 1
…troscope Classification: Class 11, 21 CFR 876.1 500, FDS Predicate Device [21 CFR 807.92(a)(3)J * Fujinon EG-400HR -K944620 * Fujinon EG-200FP - K944759 The 05 changes were described and cleared by FDA in the 5 10(k) submission for the Fujinon Double Bal- loon Enteroseopy Sy…
Fujinon, Inc.19955

Also cleared against K944620: 4 other devices →

What descends from it? (39)

See all 39

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

NumberDeviceApplicantDecidedDescendants
K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.201425
K063316Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc.200710
K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.20156

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?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K132210 (Fujifilm Medical Systems U.S.A, Inc., 2014) has gone furthest, with 25 descendants of its own.
  • 4 other devices also cite its predicate K944620.

How does its category compare?

All FDS devices

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

FDA decisions per year · FDS

8in 2025

2007: 22010: 12011: 12012: 32013: 22014: 22015: 22016: 12017: 12018: 62019: 52020: 22021: 52022: 22023: 32024: 52025: 82026 (partial year): 7
2007high 8 (2025) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDS

211in 2025

2012: 181 days median2018: 167 days median2019: 175 days median2021: 78 days median2023: 133 days median2024: 220 days median2025: 211 days median2026 (partial year): 164 days median
2007high 220 (2024) · low 78 (2021)2026

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

Recalls per year · FDS

2in 2024

2013: 12016: 12020: 22024: 2
2007high 2 (2020) · low 0 (2007)2026

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

Adverse event reports per year · FDS

18,905in 2025

2007: 272008: 112009: 212010: 452011: 362012: 352013: 82014: 232015: 292016: 1082017: 1782018: 3042019: 1,3762020: 6012021: 1,7552022: 6,2162023: 9,8742024: 9,2582025: 18,905
2007high 18,905 (2025) · low 8 (2013)2025

MAUDE reports naming product code FDS, 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
20072—027
20080—011
20090—021
20101—045
20111—036
20123181035
20132—18
20142—023
20152—029
20161—1108
20171—0178
201861670304
2019517501,376
20202—2601
202157801,755
20222—06,216
2023313309,874
2024522029,258
20258211018,905
202671640—

What is it indicated for?

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

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
  • K042076Fujinon G5 Duodenscopes; G5 Duodenoscopes, ED-450XT5, ED-250XT5Fujinon, Inc. · 20044 recalls
  • 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 FDS

The FDS category page

  • K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
  • K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
  • K260856Disposable Distal Attachment D-201-13404Olympus Medical Systems Corporation · 2026
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026
  • K260573EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2026

https://510kreport.com/device/K042043 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042043: Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042043

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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