510(k) Report

510(k) · Cleared

Cleared

Fujifilm 600 Series Endoscopes

K132210510(k) TraditionalCleared Jan 10, 2014178-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. · FDF Colonoscope And Accessories, Flexible/Rigid

Cleared on Jan 10, 2014 as substantially equivalent to K112391 (Fujinon, Inc., 2012) and 2 other predicates after a 178-day review. Its family tree reaches back 3 generations to 1995. 25 later devices descend from it.

Decided
Jan 10, 2014
Review
178 days
Class
Class II
Product code
FDF
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K944759 (1995). 5 ancestors in all. 25 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor1995: 1 other ancestor2016: 2 descendants cleared2018: 3 descendants cleared2015: 1 descendant cleared2023: 4 descendants cleared2020: 2 descendants cleared2025: 4 descendants cleared2019: 4 descendants cleared2024: 3 descendants cleared2022: 1 descendant cleared2026: 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: 2 other ancestors 1 generation forward: 4 descendants2 generations forward: 13 descendants3 generations forward: 7 descendants4 generations forward: 1 descendant 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 deviceK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
  5. Descendant · cites it directly · 19 of its ownK160196 Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016
  6. Descendant · cites it directly · 18 of its ownK172916 FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and…Fujifilm Corporation · 2018
  7. Descendant · 2 generations on · 5 of its ownK183572 FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation · 2019
  8. Descendant · 2 generations on · 4 of its ownK182836 FUJIFILM Endoscope Model EG-740NFujifilm Corporation · 2019
  9. Descendant · 2 generations on · 3 of its ownK240142 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T…Fujifilm Corporation · 2024

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2015: 12016: 22018: 32019: 42020: 22022: 12023: 42024: 32025: 42026: 1
2015high 4 (2019) · low 0 (2017)2026

Most influential descendants

Showing 5 of 25 · See all
  • K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc. · 2016 · cites it directly19descendants
  • K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Fujifilm Corporation · 2018 · cites it directly18descendants
  • K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation · 2019 · 2 generations on5descendants
  • K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation · 2019 · 2 generations on4descendants
  • K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation · 2024 · 2 generations on3descendants
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)K132210Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc.2014—
+1K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc.2016—
+1K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and…Fujifilm Corporation2018—
+2K183572FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/LFujifilm Corporation2019—
+2K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation2019—
+2K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM…Fujifilm Corporation2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201620
201830
201940
202020
202210
202340
202430
202540
202610
FIG. 1 — Lineage of K132210, 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 FDF? 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 FDF device

  1. #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 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? (3)

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
*K112391Fujinon Colonoscopes
Summary page 2
…DESCRIPTION Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL112 and EC- 530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL is intended for the v…
Fujinon, Inc.2012—
*K042043Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5
Summary page 2
…600WL and EG-600WR, are modified versions of the legally marketed Fujinon Colonoscopes EC-530HL112 and EC- 530LS2 in K112391, and Fujinon G5 Gastroscope EG-450WR5 in K042043 respectively. Just like K112391, the proposed EC-600WL is intended for the visualization of the lower digestive tract, specif…
Fujinon, Inc.2004—
*K944620Series 400 Gastroenterology System
Summary page 4
…astroscope EG-450WR5 K042043 Endoscope EG-600WR ______________________ Water Tank WT-4 Water Tank WT-2 K944620 V. CONCLUSION Fujifilm 600 Series Endoscopes, EC-600WL and EG-600WR, and Water Tank WT-4 are substantiall…
Marks & Murase19952

Also cleared against K112391: 1 other device →

What descends from it? (25)

See all 25

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

NumberDeviceApplicantDecidedDescendants
K160196Fujifilm Video Colonoscope Model EC-600WL V2Fujifilm Medical Systems U.S.A, Inc.201619
K172916FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM…Fujifilm Corporation201818
K143732FUJIFILM Endoscope Models EC-600HL and EC-600LSFujifilm Medical Systems U.S.A, Inc.20152
K180341FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation20181

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 19 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, K160196 (Fujifilm Medical Systems U.S.A, Inc., 2016) has gone furthest, with 19 descendants of its own.
  • 1 other device also cites its predicate K112391.

How does its category compare?

All FDF devices

FDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · FDF

4in 2025

2007: 42008: 22009: 62010: 42011: 22012: 72013: 22014: 62015: 22016: 72017: 42018: 72019: 42020: 42021: 32022: 52023: 62024: 22025: 42026 (partial year): 5
2007high 7 (2012) · low 2 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDF

194in 2025

2007: 70 days median2009: 91 days median2010: 101 days median2012: 241 days median2014: 164 days median2016: 98 days median2017: 36 days median2018: 101 days median2019: 56 days median2020: 250 days median2021: 30 days median2022: 147 days median2023: 203 days median2025: 194 days median2026 (partial year): 147 days median
2007high 250 (2020) · low 30 (2021)2026

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

Recalls per year · FDF

8in 2023

2015: 12016: 12020: 12023: 8
2007high 8 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FDF

17,231in 2025

2007: 812008: 682009: 832010: 482011: 772012: 882013: 632014: 602015: 1002016: 1702017: 3702018: 3882019: 4172020: 6872021: 2,4442022: 8,3452023: 11,7482024: 12,1282025: 17,231
2007high 17,231 (2025) · low 48 (2010)2025

MAUDE reports naming product code FDF, 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
2007470081
20082—068
2009691083
20104101048
20112—077
20127241088
20132—063
20146164060
20152—1100
20167981170
20174360370
201871010388
20194560417
202042501687
202133002,444
2022514708,345
20236203811,748
20242—012,128
20254194017,231
202651470—

What is it indicated for?

This product is intended for use in combination with Fujinon/Fujifilm Endoscopes to deliver air and water through the Endoscope under the management of a physician in medical facilities.

Do not use this product for any other purpose.

Fujifilm 600 Series Endoscope EC-600WL: 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.

Fujifilm 600 Series Endoscope EG-600WR: 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 duodenum.

Indications for use as stated in the FDA summary.

Also cleared against K112391

1 other device cites the same predicate.

  • K142629EG-530CT, EG-530D, EC-530DL, and ES-530WE EndoscopesFujifilm Medical System U.S.A., Inc. · 2015

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

44 FDA decisions under this applicant name. See the company

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  • 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 FDF

The FDF category page

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https://510kreport.com/device/K132210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132210: Fujifilm 600 Series Endoscopes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132210

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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