510(k) Report

510(k) · Cleared

Cleared

Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P

K050907510(k) TraditionalCleared May 19, 200538-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 May 19, 2005 as substantially equivalent to K954707 (Fujinon, Inc., 1995) after a 38-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it.

Decided
May 19, 2005
Review
38 days
Class
Class II
Product code
EOQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K954707 (1995). 8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2019: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant clearedK954707 · Bronchoscope · Fujinon, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 3 descendants K954707 · Bronchoscope · Fujinon, Inc. · 19950
  1. Root · 1 generation backK954707 BronchoscopeFujinon, Inc. · 1995
  2. This deviceK050907 Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005
  3. Descendant · cites it directly · 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 · 2 generations on · 5 of its ownK183607 FUJIFILM BronchoscopeFujifilm Corporation · 2019
  5. Descendant · 3 generations on · 3 of its ownK220957 FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
  6. Descendant · 3 generations on · 0 of its ownK253137 FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026
  7. Descendant · 4 generations on · 0 of its ownK250863 FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2012: 12018: 12019: 12022: 12024: 12025: 22026: 1
2012high 2 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 8 · See all
  • K122535Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HFujifilm Medical System U.S.A., Inc. · 2012 · cites it directly7descendants
  • K183607FUJIFILM BronchoscopeFujifilm Corporation · 2019 · 2 generations on5descendants
  • K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022 · 3 generations on3descendants
  • K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026 · 3 generations on0descendants
  • K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K954707BronchoscopeFujinon, Inc.1995—
0 (this device)K050907Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc.2005—
+1K122535Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HFujifilm Medical System U.S.A., Inc.2012—
+2K183607FUJIFILM BronchoscopeFujifilm Corporation2019—
+3K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton2022—
+3K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation2026—
+4K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201810
201910
202210
202410
202520
202610
FIG. 1 — Lineage of K050907, 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), 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. #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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K954707Bronchoscope
Summary page 1
…and EB-270P Common Name: Bronchoscope Classification: Class II, 21 CFR 874.4680, EOQ Predicate Device [21 CFR 807.92(a)(3)I * Fujinon EB-310S (K954707) TheG5 Technology has received FDA marketing clearance in the following 510(k) Premarket Notifications: * K042076 Fuji…
Fujinon, Inc.1995—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K122535Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HFujifilm Medical System U.S.A., Inc.20127

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?

  • Its one ancestor has no recall.
  • Of its descendants, K122535 (Fujifilm Medical System U.S.A., Inc., 2012) has gone furthest, with 7 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—

What is it indicated for?

The device is intended for the observation, diagnosis, and endoscopic treatment of the trachea and bronchial tree.

Indications for use as stated in the FDA summary.

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/K050907 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050907: Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050907

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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