510(k) Report

510(k) · Cleared

Cleared

Bronchoscope

K954707510(k) TraditionalCleared Nov 22, 199541-day reviewClass II21 CFR 874.4680

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Fujinon, Inc. · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Nov 22, 1995 after a 41-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.

Decided
Nov 22, 1995
Review
41 days
Class
Class II
Product code
EOQ
Recalls
None
Predicates
0

9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2012: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK954707 BronchoscopeFujinon, Inc. · 1995
  2. Descendant · cites it directly · 8 of its ownK050907 Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005
  3. Descendant · 2 generations on · 7 of its ownK122535 Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and…Fujifilm Medical System U.S.A., Inc. · 2012
  4. Descendant · 3 generations on · 5 of its ownK183607 FUJIFILM BronchoscopeFujifilm Corporation · 2019
  5. Descendant · 4 generations on · 3 of its ownK220957 FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
  6. Descendant · 4 generations on · 0 of its ownK253137 FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2005: 12012: 12018: 12019: 12022: 12024: 12025: 22026: 1
2005high 2 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 9 · See all
  • K050907Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005 · cites it directly8descendants
  • K122535Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HFujifilm Medical System U.S.A., Inc. · 2012 · 2 generations on7descendants
  • K183607FUJIFILM BronchoscopeFujifilm Corporation · 2019 · 3 generations on5descendants
  • K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022 · 4 generations on3descendants
  • K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954707BronchoscopeFujinon, Inc.1995—
+1K050907Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc.2005—
+2K122535Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HFujifilm Medical System U.S.A., Inc.2012—
+3K183607FUJIFILM BronchoscopeFujifilm Corporation2019—
+4K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton2022—
+4K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201210
201810
201910
202210
202410
202520
202610
FIG. 1 — Lineage of K954707, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050907Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc.20058

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?

  • Of its descendants, K050907 (Fujinon, Inc., 2005) has gone furthest, with 8 descendants of its own.

How does its category compare?

All EOQ devices

EOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EOQ

20in 2025

2007: 22008: 22009: 32012: 22013: 42014: 32015: 62016: 32017: 42018: 72019: 112020: 102021: 152022: 112023: 122024: 132025: 202026 (partial year): 9
2007high 20 (2025) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOQ

147in 2025

2009: 24 days median2013: 178 days median2014: 302 days median2015: 206 days median2016: 262 days median2017: 136 days median2018: 212 days median2019: 147 days median2020: 103 days median2021: 169 days median2022: 134 days median2023: 160 days median2024: 130 days median2025: 147 days median2026 (partial year): 206 days median
2007high 302 (2014) · low 24 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EOQ

25in 2025

2011: 12012: 42016: 12019: 12020: 12021: 92022: 52023: 18, 4 Class I2024: 42025: 25, 24 Class I
2007high 25 (2025) · low 0 (2007)2026

Class I (28 since 2007) Class II/III not classified

Adverse event reports per year · EOQ

6,546in 2025

2007: 392008: 872009: 1142010: 1002011: 962012: 932013: 932014: 982015: 1322016: 2972017: 3372018: 2792019: 6542020: 5152021: 1,3582022: 2,5412023: 5,0642024: 6,0512025: 6,546
2007high 6,546 (2025) · low 39 (2007)2025

MAUDE reports naming product code EOQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—039
20082—087
20093240114
20100—0100
20110—196
20122—493
20134178093
20143302098
201562060132
201632621297
201741360337
201872120279
2019111471654
2020101031515
20211516991,358
20221113452,541
20231216018 (4)5,064
20241313046,051
20252014725 (24)6,546
202692060—

More from Fujinon, Inc.

30 FDA decisions under this applicant name. See the company

  • K120446Fujinon/Fujifilm Ultrasonic Endoscope EG-530UR2 and EG-530UT2Fujinon, Inc. · 20121 recall
  • K112391Fujinon ColonoscopesFujinon, Inc. · 2012
  • K102466Fujinon Epx-4440HD Digital Video ProcessorFujinon, Inc. · 2011
  • K111243Fujinon Ultrasonic ProcessorFujinon, Inc. · 2011
  • K091773Fujinon Sterile OvertubesFujinon, Inc. · 2009

Recent decisions in EOQ

The EOQ category page

  • K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd. · 2026
  • K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2026
  • K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U)…Flexicare Medical Limited. · 2026
  • K260382MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026
  • K254037LungFlow Airway CatheterFree Flow Medical, Inc. · 2026

https://510kreport.com/device/K954707 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954707: Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954707

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026