510(k) Report

510(k) · Cleared

Cleared

VB-1830/VB-1530, Video Bronchoscope

K934920510(k) TraditionalCleared Jan 26, 1994103-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

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

Cleared on Jan 26, 1994 after a 103-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 94 later devices descend from it.

Decided
Jan 26, 1994
Review
103 days
Class
Class II
Product code
EOQ
Recalls
None
Predicates
0

94 later devices descend from it, 5 citing it directly.

Descendants, by year cleared 1996: 11 descendants cleared2002: 2 descendants cleared2008: 2 descendants cleared1997: 1 descendant cleared2004: 2 descendants cleared2009: 3 descendants cleared2007: 2 descendants cleared2006: 2 descendants cleared2010: 3 descendants cleared2012: 7 descendants cleared2005: 1 descendant cleared2014: 7 descendants cleared2018: 6 descendants cleared2017: 6 descendants cleared2011: 2 descendants cleared2015: 3 descendants cleared2026: 1 descendant cleared2016: 6 descendants cleared2019: 8 descendants cleared2013: 2 descendants cleared2020: 5 descendants cleared2021: 4 descendants cleared2024: 3 descendants cleared2025: 1 descendant cleared2022: 3 descendants cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK934920 VB-1830/VB-1530, Video BronchoscopePentax Precision Instrument Corp. · 1994
  2. Descendant · cites it directly · 72 of its ownK951574 EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
  3. Descendant · cites it directly · 42 of its ownK951579 EC-3800TL, Video ColonoscopePentax Precision Instrument Corp. · 1996 · Recalled
  4. Descendant · 2 generations on · 39 of its ownK961570 Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes…Pentax Precision Instrument Corp. · 1996 · Recalled
  5. Descendant · 2 generations on · 39 of its ownK961563 EC-384OTL, Video ColonscopePentax Precision Instrument Corp. · 1996
  6. Descendant · 2 generations on · 38 of its ownK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004

Showing 5 of 94 descendants. See all descendants

Descendants cleared per year

1996: 111997: 12002: 22004: 22005: 12006: 22007: 22008: 22009: 32010: 32011: 22012: 72013: 22014: 72015: 32016: 62017: 62018: 62019: 82020: 52021: 42022: 32023: 12024: 32025: 12026: 1
1996high 11 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 94 · See all
  • K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp. · 1996 · cites it directly72descendants
  • K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp. · 1996 · cites it directly42descendants
  • K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp. · 1996 · 2 generations on39descendants
  • K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp. · 1996 · 2 generations on39descendants
  • K032688Colonosight Model 510BSightline Technologies, Ltd. · 2004 · 2 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K934920VB-1830/VB-1530, Video BronchoscopePentax Precision Instrument Corp.1994—
+1K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp.19963
+1K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp.19961
+2K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp.19961
+2K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp.1996—
+2K032688Colonosight Model 510BSightline Technologies, Ltd.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
1996110
199710
200220
200420
200510
200620
200720
200820
200930
201030
201120
201270
201320
201470
201530
201660
201760
201860
201980
202050
202140
202230
202310
202430
202510
202610
FIG. 1 — Lineage of K934920, 1994–2026Source: 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? (94)

See all 94

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

NumberDeviceApplicantDecidedDescendants
K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp.199672
K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp.199642
K963056ED-3410, Video DuodenoscopePentax Precision Instrument Corp.19969
K023376EB-1830T3, Video BronchoscopePentax Precision Instrument Corp.20026
K951577ES-3800, Video SigmoidoscopePentax Precision Instrument Corp.19961

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, K951574 (Pentax Precision Instrument Corp., 1996) has gone furthest, with 72 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 Pentax Precision Instrument Corp.

67 FDA decisions under this applicant name. See the company

  • K041395EG-3630URPentax Precision Instrument Corp. · 2004
  • K041397EG-3830UTPentax Precision Instrument Corp. · 20041 recall
  • 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/K934920 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934920: VB-1830/VB-1530, 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/K934920

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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