510(k) Report

510(k) · Cleared

Cleared

Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H

K122535510(k) TraditionalCleared Dec 13, 2012115-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

Fujifilm Medical System U.S.A., Inc. · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Dec 13, 2012 as substantially equivalent to K050907 (Fujinon, Inc., 2005) after a 115-day review. Its family tree reaches back 2 generations to 1995. 7 later devices descend from it.

Decided
Dec 13, 2012
Review
115 days
Class
Class II
Product code
EOQ
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K954707 (1995). 7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2019: 1 descendant cleared2018: 1 descendant cleared2022: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants cleared2024: 1 descendant clearedK954707 · Bronchoscope · Fujinon, Inc. · 1995K050907 · Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P · Fujinon, Inc. · 20051995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 3 descendants K050907 · Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P · Fujinon, Inc. · 2005K954707 · Bronchoscope · Fujinon, Inc. · 19950
  1. Root · 2 generations backK954707 BronchoscopeFujinon, Inc. · 1995
  2. 1 generation backK050907 Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc. · 2005
  3. This deviceK122535 Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and…Fujifilm Medical System U.S.A., Inc. · 2012
  4. Descendant · cites it directly · 5 of its ownK183607 FUJIFILM BronchoscopeFujifilm Corporation · 2019
  5. Descendant · 2 generations on · 3 of its ownK220957 FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022
  6. Descendant · 2 generations on · 0 of its ownK253137 FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026
  7. Descendant · 3 generations on · 0 of its ownK250863 FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025
  8. Descendant · 3 generations on · 0 of its ownK244017 FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2018: 12019: 12022: 12024: 12025: 22026: 1
2018high 2 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 7 · See all
  • K183607FUJIFILM BronchoscopeFujifilm Corporation · 2019 · cites it directly5descendants
  • K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton · 2022 · 2 generations on3descendants
  • K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation · 2026 · 2 generations on0descendants
  • K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation · 2025 · 3 generations on0descendants
  • K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954707BronchoscopeFujinon, Inc.1995—
−1K050907Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270PFujinon, Inc.2005—
0 (this device)K122535Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530HFujifilm Medical System U.S.A., Inc.2012—
+1K183607FUJIFILM BronchoscopeFujifilm Corporation2019—
+2K220957FUJIFILM Endoscope Model EB-710PFujifilm Corporaton2022—
+2K253137FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TFujifilm Corporation2026—
+3K250863FUJIFILM Ultrasonic Endoscope EB-710USFujifilm Corporation2025—
+3K244017FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000Fujifilm Corporation2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
201910
202210
202410
202520
202610
FIG. 1 — Lineage of K122535, 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
*K050907Fujinon G5 Bronchoscopes, Models EB-470S, EB-250S, and EB-270P
Summary page 3
…t to the following device: ILeqally Marketed Devices) 510(k j# IFujinon G5 Bronchoscopes IK050907 Comparison is outlined in the table below, %; Legallymrarketed, 'Fujini…
Fujinon, Inc.2005—

What descends from it? (7)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K183607FUJIFILM BronchoscopeFujifilm Corporation20195
K171291FUJIFILM Bronchoscope Model EB-530PFujifilm Medical Systems U.S.A, Inc.20180

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 17 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K183607 (Fujifilm Corporation, 2019) has gone furthest, with 5 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. 2012, this device’s year, is highlighted.

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?

This 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 Fujifilm Medical System U.S.A., Inc.

74 FDA decisions under this applicant name. See the company

  • K163675Processor VP-7000, Light Source BL-7000Fujifilm Medical System U.S.A., Inc. · 2017
  • K153206Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1Fujifilm Medical System U.S.A., Inc. · 2016
  • K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016
  • K152138FDR D-EVO GL Flat Panel Detector SystemFujifilm Medical System U.S.A., Inc. · 2015
  • K150221EPX-4440HD and EPX-4400HD with FICEFujifilm Medical System U.S.A., Inc. · 2015

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/K122535 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122535: Fujinon/Fujifilm EB-530 Series Bronchoscopes (EB-530S, EB-530T and EB-530H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122535

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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