510(k) Report

510(k) · Cleared

Cleared

Epm-3300 Video Processor

K934918510(k) TraditionalCleared Feb 7, 1994115-day reviewClass II21 CFR 876.1500

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. · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology

Cleared on Feb 7, 1994 after a 115-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 87 later devices descend from it.

Decided
Feb 7, 1994
Review
115 days
Class
Class II
Product code
FET
Recalls
None
Predicates
0

87 later devices descend from it, 12 citing it directly.

Descendants, by year cleared 1996: 11 descendants cleared2002: 1 descendant cleared2007: 2 descendants cleared1997: 1 descendant cleared2004: 2 descendants cleared2009: 3 descendants cleared2006: 2 descendants cleared2008: 1 descendant cleared2010: 3 descendants cleared2012: 7 descendants cleared2005: 1 descendant cleared2015: 3 descendants cleared2011: 2 descendants cleared2017: 6 descendants cleared2026: 1 descendant cleared2018: 5 descendants cleared2014: 6 descendants cleared2016: 6 descendants cleared2019: 6 descendants cleared2013: 2 descendants cleared2020: 4 descendants cleared2021: 4 descendants cleared2024: 3 descendants cleared2022: 3 descendants cleared2025: 1 descendant cleared2023: 1 descendant cleared1990200020102020
  1. This deviceK934918 Epm-3300 Video ProcessorPentax 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 · cites it directly · 39 of its ownK961570 Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes…Pentax Precision Instrument Corp. · 1996 · Recalled
  5. Descendant · cites it directly · 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 87 descendants. See all descendants

Descendants cleared per year

1996: 111997: 12002: 12004: 22005: 12006: 22007: 22008: 12009: 32010: 32011: 22012: 72013: 22014: 62015: 32016: 62017: 62018: 52019: 62020: 42021: 42022: 32023: 12024: 32025: 12026: 1
1996high 11 (1996) · low 0 (1998)2026

Most influential descendants

Showing 5 of 87 · 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 · cites it directly39descendants
  • K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp. · 1996 · cites it directly39descendants
  • 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)K934918Epm-3300 Video ProcessorPentax Precision Instrument Corp.1994—
+1K951574EC-3800L, Video ColonoscopePentax Precision Instrument Corp.19963
+1K951579EC-3800TL, Video ColonoscopePentax Precision Instrument Corp.19961
+1K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp.19961
+1K961563EC-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
200210
200420
200510
200620
200720
200810
200930
201030
201120
201270
201320
201460
201530
201660
201760
201850
201960
202040
202140
202230
202310
202430
202510
202610
FIG. 1 — Lineage of K934918, 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 FET? 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 FET device

  1. #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 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? (87)

See all 87

12 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
K961570Kec-3840L/F, Video Colonoscope (*L or F in Model Number Denotes Length)Pentax Precision Instrument Corp.199639
K961563EC-384OTL, Video ColonscopePentax Precision Instrument Corp.199639
K961564EG-2940, Video GastroscopePentax Precision Instrument Corp.199610
K013640EG-3630UR, Ultrasund Video GastroscopePentax Precision Instrument Corp.20029
K963056ED-3410, Video DuodenoscopePentax Precision Instrument Corp.19969
K951577ES-3800, Video SigmoidoscopePentax Precision Instrument Corp.19961
K962897EG-3400, Video GastroscopePentax Precision Instrument Corp.19960
K962460EG-3800T, Video GastroscopePentax Precision Instrument Corp.19960

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 FET devices

FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FET

6in 2025

2007: 12008: 22009: 22010: 12011: 22012: 22013: 22015: 22016: 12017: 32018: 32019: 32020: 52021: 12022: 22023: 12024: 22025: 62026 (partial year): 3
2007high 6 (2025) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FET

166in 2025

2017: 119 days median2018: 98 days median2019: 25 days median2020: 106 days median2025: 166 days median2026 (partial year): 69 days median
2007high 166 (2025) · low 25 (2019)2026

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

Recalls per year · FET

1in 2024

2023: 22024: 1
2007high 2 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FET

14,530in 2025

2007: 22008: 12009: 62010: 32011: 72012: 112013: 82014: 32015: 32016: 252017: 662018: 672019: 722020: 3,0432021: 5,3002022: 6,1562023: 8,1992024: 13,1532025: 14,530
2007high 14,530 (2025) · low 1 (2008)2025

MAUDE reports naming product code FET, 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
20071—02
20082—01
20092—06
20101—03
20112—07
20122—011
20132—08
20140—03
20152—03
20161—025
20173119066
2018398067
2019325072
2020510603,043
20211—05,300
20222—06,156
20231—28,199
20242—113,153
20256166014,530
20263690—

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

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https://510kreport.com/device/K934918 · printed Nov 6, 2026

Cite this page

510(k) Report. “K934918: Epm-3300 Video Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K934918

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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