510(k) · Cleared
ClearedFUJIFILM Endoscope Model EB-710P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporaton · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Nov 10, 2022 as substantially equivalent to K183607 (Fujifilm Corporation, 2019) after a 223-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 10, 2022
- Review
- 223 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K954707 (1995). 3 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK954707 BronchoscopeFujinon, Inc. · 1995
- 3 generations backK050907 Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005
- 2 generations backK122535 Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and…Fujifilm Medical System U.S.A., Inc. · 2012
- 1 generation backK183607 FUJIFILM BronchoscopeFujifilm Corporation · 2019
- This deviceK220957 FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
- Descendant · cites it directly · 0 of its ownK250863 FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025
- Descendant · cites it directly · 0 of its ownK244017 FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation · 2025
- Descendant · cites it directly · 0 of its ownK240075 FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation · 2024
Most influential descendants
Showing 3 of 3 · See all- K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025 · cites it directly0descendants
- K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation · 2025 · cites it directly0descendants
- K240075FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K954707 | Bronchoscope | Fujinon, Inc. | 1995 | — |
| −3 | K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P | Fujinon, Inc. | 2005 | — |
| −2 | K122535 | Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| −1 | K183607 | FUJIFILM Bronchoscope | Fujifilm Corporation | 2019 | — |
| 0 (this device) | K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | 2022 | — |
| +1 | K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | 2025 | — |
| +1 | K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025 | — |
| +1 | K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | K183607 | FUJIFILM BronchoscopeSummary page 4…Regulation Description: Bronchoscope Review Panel: Ear Nose & Throat Predicate Device: • FUJIFILM Endoscope Model EB-580S (K183607) Reference Devices: • FUJIFILM Endoscope Model EC-760S-V/L (K190649) • OLYMPUS Endoscope Model BF-P190 (K201758) I… | 2019 |
| † | K190649 | FUJIFILM Endoscope Model EC-760S-V/L | 2019 |
| † | K201758 | EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope… | 2021 |
What descends from it? (3)
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 27 years and passes through 4 companies; a new generation was cleared every 7.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250863 (Fujifilm Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K183607.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
FUJIFILM Endoscope Model EB-71 OP 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 as stated in the FDA summary.
https://510kreport.com/device/K220957 · printed Nov 5, 2026
Cite this page
510(k) Report. “K220957: FUJIFILM Endoscope Model EB-710P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K220957
Report an extraction error
Are you the manufacturer?
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