510(k) Report

510(k) · Cleared

Cleared

Pentax Flexible Driodenofiberscope

K812810510(k) TraditionalCleared Nov 17, 198142-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. · FAK Panendoscope (Gastroduodenoscope)

Cleared on Nov 17, 1981 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 88 devices in its family, counting itself, has a Class I recall. 87 later devices descend from it.

Decided
Nov 17, 1981
Review
42 days
Class
Class II
Product code
FAK
Recalls
None
Predicates
0

87 later devices descend from it, 1 citing it directly. 1 of the 88 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 1997: 1 descendant cleared2001: 2 descendants cleared2002: 2 descendants cleared2003: 3 descendants cleared2007: 3 descendants cleared2004: 3 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2012: 5 descendants cleared2009: 4 descendants cleared2011: 1 descendant cleared2015: 3 descendants cleared2016: 6 descendants cleared2010: 1 descendant cleared2008: 1 descendant cleared2020: 6 descendants cleared, 1 with a Class I recall12019: 7 descendants cleared2018: 6 descendants cleared2025: 6 descendants cleared2013: 3 descendants cleared2023: 5 descendants cleared2014: 3 descendants cleared2017: 4 descendants cleared2026: 3 descendants cleared2024: 2 descendants cleared2021: 1 descendant cleared2022: 4 descendants cleared19801990200020102020
  1. This deviceK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
  2. Descendant · cites it directly · 86 of its ownK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
  3. Descendant · 2 generations on · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
  4. Descendant · 3 generations on · 44 of its ownK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
  5. Descendant · 3 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
  6. Descendant · 4 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled

Showing 5 of 87 descendants. See all descendants

Descendants cleared per year

1997: 12001: 22002: 22003: 32004: 32005: 12006: 12007: 32008: 12009: 42010: 12011: 12012: 52013: 32014: 32015: 32016: 62017: 42018: 62019: 72020: 62021: 12022: 42023: 52024: 22025: 62026: 3
1997high 7 (2019) · low 0 (1998)2026

Class I recalls in this family

  • K193517 ViziShot 2 FLEX7 generations on · 2020

Most influential descendants

Showing 5 of 87 · See all
  • K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · cites it directly86descendants
  • K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · 2 generations on59descendants
  • K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003 · 3 generations on44descendants
  • K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 3 generations on43descendants
  • K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 4 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K812810Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp.1981—
+1K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp.19972
+2K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd.20012
+3K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd.2003—
+3K042140Olympus BF Type UC160-OL8Olympus Corporation20041
+4K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation20055

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200120
200220
200330
200430
200510
200610
200730
200810
200940
201010
201110
201250
201330
201430
201530
201660
201740
201860
201970
202061
202110
202240
202350
202420
202560
202630
FIG. 1 — Lineage of K812810, 1981–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (87)

See all 87

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

NumberDeviceApplicantDecidedDescendants
K961974FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp.199786

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K961974 (Pentax Precision Instrument Corp., 1997) has gone furthest, with 86 descendants of its own.

How does its category compare?

All FAK devices

FAK Panendoscope (Gastroduodenoscope): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAK

FDA has decided no FAK device since 2007.

Median 510(k) review, days · FAK

Too few FAK 510(k)s in any year since 2007 to give a median.

Recalls per year · FAK

No recall names FAK since 2007.

Adverse event reports per year · FAK

1in 2010

2008: 22009: 12010: 1
2007high 2 (2008) · low 0 (2007)2025

MAUDE reports naming product code FAK, 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—00
20080—02
20090—01
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

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 FAK

The FAK category page

  • K760822Model TX-8 PanendoscopeAmerican Cystocope Makers, Inc. · 1976

https://510kreport.com/device/K812810 · printed Nov 6, 2026

Cite this page

510(k) Report. “K812810: Pentax Flexible Driodenofiberscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K812810

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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