510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

EB-1830T3, Video Bronchoscope

K023376510(k) SpecialCleared Oct 16, 20028-day reviewClass II21 CFR 874.4680Recalls 3

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

Pentax Precision Instrument Corp. · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on Oct 16, 2002 as substantially equivalent to K934920 (Pentax Precision Instrument Corp., 1994) after an 8-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it. It has been recalled 3 times.

Decided
Oct 16, 2002
Review
8 days
Class
Class II
Product code
EOQ
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K934920 (1994). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2014: 1 descendant cleared2018: 1 descendant cleared2019: 2 descendants cleared2020: 1 descendant clearedK934920 · VB-1830/VB-1530, Video Bronchoscope · Pentax Precision Instrument Corp. · 19941990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K934920 · VB-1830/VB-1530, Video Bronchoscope · Pentax Precision Instrument Corp. · 19940
  1. Root · 1 generation backK934920 VB-1830/VB-1530, Video BronchoscopePentax Precision Instrument Corp. · 1994
  2. This deviceK023376 EB-1830T3, Video BronchoscopePentax Precision Instrument Corp. · 2002
  3. Descendant · cites it directly · 5 of its ownK081518 Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008
  4. Descendant · 2 generations on · 3 of its ownK131946 Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · Recalled
  5. Descendant · 3 generations on · 1 of its ownK183516 PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc. · 2019
  6. Descendant · 4 generations on · 0 of its ownK203166 PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX…Pentax of America, Inc. · 2020
  7. Descendant · 3 generations on · 0 of its ownK183654 PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi…Pentax of America, Inc. · 2019

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2008: 12014: 12018: 12019: 22020: 1
2008high 2 (2019) · low 0 (2009)2026

Most influential descendants

Showing 5 of 6 · See all
  • K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company · 2008 · cites it directly5descendants
  • K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company · 2014 · 2 generations on3descendants
  • K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc. · 2019 · 3 generations on1descendant
  • K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc. · 2020 · 4 generations on0descendants
  • K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION…Pentax of America, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K934920VB-1830/VB-1530, Video BronchoscopePentax Precision Instrument Corp.1994—
0 (this device)K023376EB-1830T3, Video BronchoscopePentax Precision Instrument Corp.2002—
+1K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company2008—
+2K131946Entax Ultrasound Video Bronchoscope EB-1970UK + HI Visin PreirusPentax Medical Company20144
+3K183516PENTAX Medical Ultrasound Video Bronchoscope EB19-J10UPentax of America, Inc.2019—
+4K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical…Pentax of America, Inc.2020—
+3K183654PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI…Pentax of America, Inc.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201410
201810
201920
202010
FIG. 1 — Lineage of K023376, 1994–2020Source: 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K934920VB-1830/VB-1530, Video Bronchoscope
Summary page 1
…Manufacturer PMN# VB-1830, Video Bronchoscope PPIC K934920 Intended Use: The EB-l83OT3, Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and ther…
Pentax Precision Instrument Corp.1994—

Also cleared against K934920: 4 other devices →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K081518Ultrasound Video Bronchoscope, Model EB-1970UKPentax Medical Company20085

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Apr 6, 2016Class IIZ-2076-2016Device DesignPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Apr 6, 2016Class IIZ-2065-2016Device DesignPentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Sep 30, 2011Not classifiedZ-0818-2012Employee errorThe wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K081518 (Pentax Medical Company, 2008) has gone furthest, with 5 descendants of its own.
  • 4 other devices also cite its predicate K934920.

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 EB-1830T3, Video Bronchoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Pulmonary Tract. The Pulmonary Tract includes, but is not restricted to, the organs; tissues; and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, and bronchial Tree (including access beyond the stem). The instrument is introduced per oral or per nasal when indications consistent with the requirement for the procedure are observed in adult and pediatric patient populations.

Indications for use as stated in the FDA summary.

Also cleared against K934920

4 other devices cite the same predicate.

  • K963056ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 19962 recalls
  • K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 19963 recalls
  • K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp. · 19961 recall
  • K951577ES-3800, Video SigmoidoscopePentax Precision Instrument Corp. · 19961 recall

More from Pentax Precision Instrument Corp.

67 FDA decisions under this applicant name. See the company

  • K041397EG-3830UTPentax Precision Instrument Corp. · 20041 recall
  • K041395EG-3630URPentax Precision Instrument Corp. · 2004
  • K041396FG-36UX Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 20041 recall
  • K031789EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
  • K023401EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003

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/K023376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023376: EB-1830T3, Video Bronchoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023376

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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