510(k) · Cleared
ClearedFUJIFILM Bronchoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Aug 23, 2019 as substantially equivalent to K122535 (Fujifilm Medical System U.S.A., Inc., 2012) after a 240-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 23, 2019
- Review
- 240 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954707 (1995). 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK954707 BronchoscopeFujinon, Inc. · 1995
- 2 generations backK050907 Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005
- 1 generation backK122535 Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and…Fujifilm Medical System U.S.A., Inc. · 2012
- This deviceK183607 FUJIFILM BronchoscopeFujifilm Corporation · 2019
- Descendant · cites it directly · 3 of its ownK220957 FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
- Descendant · cites it directly · 0 of its ownK253137 FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK250863 FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK244017 FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation · 2025
- Descendant · 2 generations on · 0 of its ownK240075 FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation · 2024
Most influential descendants
Showing 5 of 5 · See all- K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022 · cites it directly3descendants
- K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026 · cites it directly0descendants
- K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025 · 2 generations on0descendants
- K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation · 2025 · 2 generations on0descendants
- K240075FUJIFILM Endoscope Model EB-710XTFUJIFILM Healthcare Americas Corporation · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954707 | Bronchoscope | Fujinon, Inc. | 1995 | — |
| −2 | K050907 | Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P | Fujinon, Inc. | 2005 | — |
| −1 | K122535 | Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H | Fujifilm Medical System U.S.A., Inc. | 2012 | — |
| 0 (this device) | K183607 | FUJIFILM Bronchoscope | Fujifilm Corporation | 2019 | — |
| +1 | K220957 | FUJIFILM Endoscope Model EB-710P | Fujifilm Corporaton | 2022 | — |
| +1 | K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840T | Fujifilm Corporation | 2026 | — |
| +2 | K250863 | FUJIFILM Ultrasonic Endoscope EB-710US | Fujifilm Corporation | 2025 | — |
| +2 | K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Fujifilm Corporation | 2025 | — |
| +2 | K240075 | FUJIFILM Endoscope Model EB-710XT | FUJIFILM Healthcare Americas Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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 |
|---|---|---|---|
| * | K122535 | Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HSummary page 4…Product Codes Bronchoscope (flexible or rigid) and accessories 21 CFR 874.4680 EOQ Predicate Devices: • FUJIFILM Video Bronchoscopes EB-530S and EB-530T (K122535) Intended Use / Indications for Use FUJIFILM Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, an… | 2012 |
What descends from it? (5)
2 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 24 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220957 (Fujifilm Corporaton, 2022) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K122535.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 Bronchoscopes EB-580S and EB-580T are intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183607: FUJIFILM Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183607
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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