510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

ED-3410, Video Duodenoscope

K963056510(k) TraditionalCleared Oct 10, 199665-day reviewClass II21 CFR 876.1500Recalls 2

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. · FDT Duodenoscope And Accessories, Flexible/Rigid

Cleared on Oct 10, 1996 as substantially equivalent to K832006 (Pentax Precision Instrument Corp., 1983) and 2 other predicates after a 65-day review. Its family tree reaches back 1 generation to 1983. 9 later devices descend from it. It has been recalled 2 times.

Decided
Oct 10, 1996
Review
65 days
Class
Class II
Product code
FDT
Recalls
2
Predicates
3

Its longest line of descent runs back 1 generation to K832006 (1983). 3 ancestors in all. 9 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1994: 2 other ancestors2009: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2019: 2 descendants cleared2021: 2 descendants cleared2024: 1 descendant clearedK832006 · Pentax FD-34A Duodenofiberscope · Pentax Precision Instrument Corp. · 198319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants K832006 · Pentax FD-34A Duodenofiberscope · Pentax Precision Instrument Corp. · 19830
  1. Root · 1 generation backK832006 Pentax FD-34A DuodenofiberscopePentax Precision Instrument Corp. · 1983
  2. This deviceK963056 ED-3410, Video DuodenoscopePentax Precision Instrument Corp. · 1996
  3. Descendant · cites it directly · 8 of its ownK092710 Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · Recalled
  4. Descendant · 2 generations on · 6 of its ownK161222 PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · Recalled
  5. Descendant · 3 generations on · 5 of its ownK181522 PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical…Pentax of America, Inc. · 2018
  6. Descendant · 2 generations on · 4 of its ownK163614 PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical · 2017
  7. Descendant · 3 generations on · 3 of its ownK192245 Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc. · 2019 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 12017: 12018: 22019: 22021: 22024: 1
2009high 2 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all
  • K092710Pentax ED-3490TK, Video DuodenoscopePentax Medical Company · 2009 · cites it directly8descendants
  • K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical · 2018 · 2 generations on6descendants
  • K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video DuodenoscopePentax of America, Inc. · 2018 · 3 generations on5descendants
  • K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical · 2017 · 2 generations on4descendants
  • K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc. · 2019 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K832006Pentax FD-34A DuodenofiberscopePentax Precision Instrument Corp.1983—
0 (this device)K963056ED-3410, Video DuodenoscopePentax Precision Instrument Corp.1996—
+1K092710Pentax ED-3490TK, Video DuodenoscopePentax Medical Company20092
+2K161222PENTAX MEDICAL ED-3490TK, Video DuodenoscopePentax Medical20181
+3K181522PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video…Pentax of America, Inc.2018—
+2K163614PENTAX Medical ED34-i10T, Video DuodenoscopePentax Medical2017—
+3K192245Pentax Medical Video Duodenoscope ED34-i10T2Pentax of America, Inc.20191

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201710
201820
201920
202120
202410
FIG. 1 — Lineage of K963056, 1983–2024Source: 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 FDT? 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 FDT device

  1. #1 K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM…score 13.7 · 10 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? (3)

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
*K832006Pentax FD-34A Duodenofiberscope
Summary page 1
…410, Video Duodenoscope Classification Name: Duodenoscope (Esophago Gastro) (78FDT), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FD-34A, Fiber Duodenoscope Pentax K832006 2. VB-1530/ 1830, Video Bronchoscope Pentax K934920 3. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The ED-3…
Pentax Precision Instrument Corp.1983—
*K934920VB-1830/VB-1530, Video Bronchoscope
Summary page 1
…scope (Esophago Gastro) (78FDT), 876.1500 3. PREDICATED DEVICE(S) INFORMATION: 1. FD-34A, Fiber Duodenoscope Pentax K832006 2. VB-1530/ 1830, Video Bronchoscope Pentax K934920 3. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The ED-3410, Video Duodenoscope, must be used with a Video P…
Pentax Precision Instrument Corp.1994—
*K934918Epm-3300 Video Processor
Summary page 1
…. PREDICATED DEVICE(S) INFORMATION: 1. FD-34A, Fiber Duodenoscope Pentax K832006 2. VB-1530/ 1830, Video Bronchoscope Pentax K934920 3. EPM-3300, Video Processor Pentax K934918 4. DEVICE DESCRIPTION: The ED-3410, Video Duodenoscope, must be used with a Video Processor (a software controlled device). The…
Pentax Precision Instrument Corp.1994—

Also cleared against K832006: 1 other device →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K092710Pentax ED-3490TK, Video DuodenoscopePentax Medical Company20098

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 17, 2017Class IIZ-2713-2017Device DesignPentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Apr 6, 2016Class IIZ-2277-2016Device DesignPentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K092710 (Pentax Medical Company, 2009) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K832006.

How does its category compare?

All FDT devices

FDT Duodenoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FDT

2in 2025

2008: 12009: 12011: 12016: 12017: 22018: 32019: 52020: 42021: 22022: 12024: 22025: 22026 (partial year): 2
2007high 5 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FDT

72in 2020

2018: 63 days median2019: 88 days median2020: 72 days median
2007high 88 (2019) · low 63 (2018)2026

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

Recalls per year · FDT

7so far in 2026, the most since 2007

2015: 12016: 12018: 12021: 12023: 32025: 12026 (partial year): 7
2007high 7 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FDT

3,946in 2025

2007: 42008: 112009: 182010: 122011: 102012: 152013: 182014: 362015: 2462016: 2472017: 7912018: 4812019: 1,3472020: 8222021: 1,2702022: 2,6192023: 3,0502024: 3,0192025: 3,946
2007high 3,946 (2025) · low 4 (2007)2025

MAUDE reports naming product code FDT, 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
20070—04
20081—011
20091—018
20100—012
20111—010
20120—015
20130—018
20140—036
20150—1246
20161—1247
20172—0791
20183631481
201958801,347
20204720822
20212—11,270
20221—02,619
20230—33,050
20242—03,019
20252—13,946
20262—7—

What is it indicated for?

The ED-3410, Video Duodenoscope, is intended to provide optical visualization (via a video monitor) of, and therapeutic access to, the Upper Gastrointestinal Tract and Biliary Tract. The Upper Gastrointestinal Tract and Biliary Tract includes, but is not limited to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile Duct, Hepatic Duct, and Cystic Duct. The instrument is introduced per orally when indications consistent with the requirement for the procedure are observed in Adult and Pediatric patient populations.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K832006

1 other device cites the same predicate.

  • K961568ED-344OTPentax Precision Instrument Corp. · 1996

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 FDT

The FDT category page

  • K251861FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000Fujifilm Corporation · 2026
  • K253646Single Use Distal Cover MAJ-2315 (MAJ-2315)Olympus Medical Systems Corp. · 2026
  • K251867Evis Exera Iii Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 20251 recall
  • K250701Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V)Olympus Medical Systems Corp. · 2025
  • K233942PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical…Pentax of America, Inc. · 2024

https://510kreport.com/device/K963056 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963056: ED-3410, Video Duodenoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963056

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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