510(k) · Cleared
ClearedFujinon Model EG-530N Trans Nasal Insertion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujinon, Inc. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on Mar 16, 2007 as substantially equivalent to K042043 (Fujinon, Inc., 2004) after a 134-day review. Its family tree reaches back 2 generations to 1995. 10 later devices descend from it.
- Decided
- Mar 16, 2007
- Review
- 134 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944759 (1995). 3 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK944759 200 Series Gastro-Intestinal Video SystemFujinon, Inc. · 1995 · Recalled
- 1 generation backK042043 Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Fujinon, Inc. · 2004
- This deviceK063316 Fujinon Model EG-530N Trans Nasal InsertionFujinon, Inc. · 2007
- Descendant · cites it directly · 4 of its ownK182836 FUJIFILM Endoscope Model EG-740NFujifilm Corporation · 2019
- Descendant · 2 generations on · 3 of its ownK240142 FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T…Fujifilm Corporation · 2024
- Descendant · cites it directly · 3 of its ownK213606 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK251708 EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025
- Descendant · 3 generations on · 1 of its ownK243260 FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K182836FUJIFILM Endoscope Model EG-740NFujifilm Corporation · 2019 · cites it directly4descendants
- K240142FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope…Fujifilm Corporation · 2024 · 2 generations on3descendants
- K213606EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2022 · cites it directly3descendants
- K251708EvoEndo Single-Use Endoscopy SystemEvoEndo, Inc. · 2025 · 2 generations on1descendant
- K243260FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860RFujifilm Corporation · 2025 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944759 | 200 Series Gastro-Intestinal Video System | Fujinon, Inc. | 1995 | 5 |
| −1 | K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5 | Fujinon, Inc. | 2004 | — |
| 0 (this device) | K063316 | Fujinon Model EG-530N Trans Nasal Insertion | Fujinon, Inc. | 2007 | — |
| +1 | K182836 | FUJIFILM Endoscope Model EG-740N | Fujifilm Corporation | 2019 | — |
| +2 | K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM… | Fujifilm Corporation | 2024 | — |
| +1 | K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2022 | — |
| +2 | K251708 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | 2025 | — |
| +3 | K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Fujifilm Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 4 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K042043 | Fujinon Inc. G5 Gastroscopes, Models EC-450WR5, EC-250WR5Summary page 2…Common, Usual, or Classification Names: Gastroscope Classification: Class [1, 21 CFR 876.1500, FDS Predicate Device [21 CFR 807.92(a)(3)] · Fujinon EG-450WR5 (K042043) The subject device have the same indications for use, material composition, viewing direction, image size, bending, repr… | 2004 |
| † | K001766 | Olympus Xgif-N200H Gastrointestinal Videoscope | 2000 |
What descends from it? (10)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 1 company; a new generation was cleared every 9.6 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K182836 (Fujifilm Corporation, 2019) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K042043.
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. 2007, 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 duodenal bulb. The device can be inserted
orally or trans nasally.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063316 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063316: Fujinon Model EG-530N Trans Nasal Insertion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063316
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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