510(k) Report

510(k) · Cleared

Cleared

EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes

K142629510(k) TraditionalCleared May 14, 2015240-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 System U.S.A., Inc. · FDS Gastroscope And Accessories, Flexible/Rigid

Cleared on May 14, 2015 as substantially equivalent to K042043 (Fujinon, Inc., 2004) and 1 other predicate after a 240-day review. Its family tree reaches back 3 generations to 1995. 6 later devices descend from it.

Decided
May 14, 2015
Review
240 days
Class
Class II
Product code
FDS
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K944759 (1995). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1995: 1 other ancestor2021: 1 descendant cleared2023: 1 descendant cleared2026: 3 descendants cleared2024: 1 descendant clearedK944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalledK041903 · Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 · Fujinon, Inc. · 2004 · recalledK112391 · Fujinon Colonoscopes · Fujinon, Inc. · 20121995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K112391 · Fujinon Colonoscopes · Fujinon, Inc. · 2012K041903 · Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 · Fujinon, Inc. · 2004 · recalledK944759 · 200 Series Gastro-Intestinal Video System · Fujinon, Inc. · 1995 · recalled0
  1. Root · 3 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
  2. 2 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
  3. 1 generation backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
  4. This deviceK142629 EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015
  5. Descendant · cites it directly · 5 of its ownK210162 Endoscope Model EI-740D/SFujifilm Corporation · 2021
  6. Descendant · 2 generations on · 2 of its ownK221551 FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton · 2023
  7. Descendant · 2 generations on · 0 of its ownK261400 Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026
  8. Descendant · 3 generations on · 0 of its ownK260824 Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026
  9. Descendant · 2 generations on · 0 of its ownK253702 Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2021: 12023: 12024: 12026: 3
2021high 3 (2026) · low 0 (2022)2026

Most influential descendants

Showing 5 of 6 · See all
  • K210162Endoscope Model EI-740D/SFujifilm Corporation · 2021 · cites it directly5descendants
  • K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton · 2023 · 2 generations on2descendants
  • K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S · 2026 · 2 generations on0descendants
  • K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation · 2026 · 3 generations on0descendants
  • K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K944759200 Series Gastro-Intestinal Video SystemFujinon, Inc.19955
−2K041903Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc.20041
−1K112391Fujinon ColonoscopesFujinon, Inc.2012—
0 (this device)K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc.2015—
+1K210162Endoscope Model EI-740D/SFujifilm Corporation2021—
+2K221551FUJIFILM Endoscope Model EI-740D/SFujifilm Corporaton2023—
+2K261400Ambu® aScope™ Gastro; Ambu® aScope™ Gastro LargeAmbu A/S2026—
+3K260824Gastrointestinal Videoscope Olympus GIF-2T1500Olympus Medical Systems Corporation2026—
+2K253702Intuitive Endoluminal Gastrointestinal System (IG1000)Intuitive Surgical, Inc.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202110
202310
202410
202630
FIG. 1 — Lineage of K142629, 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 16.5 · 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
*K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5
Summary page 4
…Sigmoidoscope and Accessories (Flexible/Rigid) 21 CFR 876.1500 FAM Predicate Devices  Fujinon Inc. G5 Gastroscopes, Model EG-450WR5 (K042043)  Fujinon Colonoscopes, EC-530HL2 (K112391) \\DC - 038036/000009 - 5759962 v11…
Fujinon, Inc.2004—
*K112391Fujinon Colonoscopes
Summary page 4
…21 CFR 876.1500 FAM Predicate Devices  Fujinon Inc. G5 Gastroscopes, Model EG-450WR5 (K042043)  Fujinon Colonoscopes, EC-530HL2 (K112391) \\DC - 038036/000009 - 5759962 v11 025…
Fujinon, Inc.2012—

Also cleared against K042043: 2 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
K210162Endoscope Model EI-740D/SFujifilm Corporation20215

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 20 years and passes through 2 companies; a new generation was cleared every 7.7 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K210162 (Fujifilm Corporation, 2021) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K042043.

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. 2015, this device’s year, is highlighted.

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 Fujifilm Endoscopes: EG-530CT, EG-530D, EC-530DL, and ES-530WE have the following indications for use: Indications for Use (EG-530CT): The EG-530CT Endoscope: This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum. Indications for Use (EG-530D): The EG-530D Endoscope: This device is intended for the visualization of the…

Read the full statement (146 words)

The Fujifilm Endoscopes: EG-530CT, EG-530D, EC-530DL, and ES-530WE have the following indications for use:

Indications for Use (EG-530CT):

The EG-530CT Endoscope: This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Indications for Use (EG-530D):

The EG-530D Endoscope: This device is intended for the visualization of the upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.

Indications for Use (EC-530DL):

The EC-530DL Endoscope: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and large intestine.

Indications for Use (ES-530WE):

The ES-530WE Endoscope: This device is intended for the visualization of the lower digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the rectum and sigmoid colon.

Indications for use as stated in the FDA summary.

Also cleared against K042043

2 other devices cite the same predicate.

  • K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
  • K063316Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc. · 2007

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

74 FDA decisions under this applicant name. See the company

  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  • K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016
  • K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2015
  • K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc. · 2015

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/K142629 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142629: EG-530CT, EG-530D, EC-530DL, and ES-530WE Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142629

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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