510(k) · Cleared
ClearedFUJIFILM 600 Series Endoscope EG-600WR v2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Aug 3, 2018 as substantially equivalent to K132210 (Fujifilm Medical Systems U.S.A, Inc., 2014) after a 177-day review. Its family tree reaches back 4 generations to 1995. 1 later device descends from it.
- Decided
- Aug 3, 2018
- Review
- 177 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K944759 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 3 generations backK041903 Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5Fujinon, Inc. · 2004 · Recalled
- 2 generations backK112391 Fujinon ColonoscopesFujinon, Inc. · 2012
- 1 generation backK132210 Fujifilm 600 Series EndoscopesFujifilm Medical Systems U.S.A, Inc. · 2014
- This deviceK180341 FUJIFILM 600 Series Endoscope EG-600WR v2Fujifilm Corporation · 2018
- Descendant · cites it directly · 0 of its ownK213095 andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited · 2022
Most influential descendants
Showing 1 of 1 · See all- K213095andorate Suction Valve, andorate Air/Water ValveGa Health Company Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −3 | K041903 | Fujinon G5 Colonoscopes, Models EC-450HL5 and EC-250HL5 | Fujinon, Inc. | 2004 | 1 |
| −2 | K112391 | Fujinon Colonoscopes | Fujinon, Inc. | 2012 | — |
| −1 | K132210 | Fujifilm 600 Series Endoscopes | Fujifilm Medical Systems U.S.A, Inc. | 2014 | — |
| 0 (this device) | K180341 | FUJIFILM 600 Series Endoscope EG-600WR v2 | Fujifilm Corporation | 2018 | — |
| +1 | K213095 | andorate Suction Valve, andorate Air/Water Valve | Ga Health Company Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
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 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K132210 | Fujifilm 600 Series EndoscopesSummary page 4…ries, 21 C.F.R. § 876.1500 Product Code: FDS Predicate Device: Fujifilm 600 Series Endoscopes EC-600WL and EG-600WR, Fujifilm Medical Systems U.S.A, K132210 Reference Devices: 1. Fujifilm Video Colonoscope Model EC-600WLv2, FUJIFILM Medical Systems U.S.A., K160196 2. Fujifilm Endosc… | 2014 |
| † | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | 2016 |
| † | K162622 | Fujifilm Endoscope Models EC-600HL and EC-600LS | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213095 | andorate Suction Valve, andorate Air/Water Valve | 2022 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 7.7 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K213095 (Ga Health Company Limited, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K132210.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
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 duodenum.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180341 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180341: FUJIFILM 600 Series Endoscope EG-600WR v2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180341
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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