510(k) · Cleared
ClearedFUJIFILM Endoscope Model EB-710XT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
FUJIFILM Healthcare Americas Corporation · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Feb 7, 2024 as substantially equivalent to K220957 (Fujifilm Corporaton, 2022) after a 28-day review. Its family tree reaches back 5 generations to 1995.
- Decided
- Feb 7, 2024
- Review
- 28 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K954707 (1995). No later device cites it as a predicate yet.
- Root · 5 generations backK954707 BronchoscopeFujinon, Inc. · 1995
- 4 generations backK050907 Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005
- 3 generations backK122535 Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and…Fujifilm Medical System U.S.A., Inc. · 2012
- 2 generations backK183607 FUJIFILM BronchoscopeFujifilm Corporation · 2019
- 1 generation backK220957 FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
- This deviceK240075 FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K954707 | Bronchoscope | Fujinon, Inc. | 1995 | — |
| −4 | K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P | Fujinon, Inc. | 2005 | — |
| −3 | K122535 | Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −2 | K183607 | FUJIFILM Bronchoscope | Fujifilm Corporation | 2019 | — |
| −1 | K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | 2022 | — |
| 0 (this device) | K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | 2024 | — |
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 EOQ? 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 EOQ device
- #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 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 |
|---|---|---|---|
| * | K220957 | FUJIFILM Endoscope Model EB-710PSummary page 5…instrument, as well as providing suction. C. Principles of Operation The proposed device function on the same principles of operation as the predicate device, EB-710P (K220957). They are bronchoscopes that can be inserted trans-nasally or perorally into the trachea and bronchial tree for observation, dia… | 2022 |
| † | K183419 | EVIS EXERA III Bronchovideoscope Olympus BF-XT190 | 2019 |
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 29 years and passes through 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K220957.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
Endoscope Model EB-710XT is a bronchoscope intended for the observation, diagnosis and
endoscopic treatment of the trachea and bronchus at medical facilities under the
management of physicians.
Never use this product for any other purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240075 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240075: FUJIFILM Endoscope Model EB-710XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240075
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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