510(k) · Cleared
ClearedFUJIFILM Endoscope Model EG-530N
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 Feb 28, 2019 as substantially equivalent to K063316 (Fujinon, Inc., 2007) after a 62-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Feb 28, 2019
- Review
- 62 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K944759 (1995). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 2 generations backK042043 Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004
- 1 generation backK063316 Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc. · 2007
- This deviceK183686 FUJIFILM Endoscope Model EG-530NFujifilm Corporation · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −2 | K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 | Fujinon, Inc. | 2004 | — |
| −1 | K063316 | Fujinon Model EG-530N Trans Nasal Insertion | Fujinon, Inc. | 2007 | — |
| 0 (this device) | K183686 | FUJIFILM Endoscope Model EG-530N | Fujifilm Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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 16.5 · 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 |
|---|---|---|---|
| * | K063316 | Fujinon Model EG-530N Trans Nasal InsertionSummary page 4…erology/Urology Classification: Endoscope and accessories, 21 C.F.R. § 876.1500 Product Code: FDS Predicate Device: Fujinon EG-530N (K063316) Reference Device: FUJIFILM Video Colonoscope EC-600WL v2 (K160196) Intended Use / Indications for Use: EG-530N is intended f… | 2007 |
| † | K160196 | Fujifilm Video Colonoscope Model EC-600WL V2 | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K063316.
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. 2019, 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?
EG-530N 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. The EG-530N can be inserted orally or transnasally.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183686 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183686: FUJIFILM Endoscope Model EG-530N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183686
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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