510(k) Report

510(k) · Cleared

Cleared

Pentax Flexible Sigmoidoscope Mod. FS-34

K792341510(k) TraditionalCleared Dec 10, 197921-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. · FAM Sigmoidoscope And Accessories, Flexible/Rigid

Cleared on Dec 10, 1979 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Dec 10, 1979
Review
21 days
Class
Class II
Product code
FAM
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1997: 1 descendant cleared19801990200020102020
  1. This deviceK792341 Pentax Flexible Sigmoidoscope Mod. FS-34Pentax Precision Instrument Corp. · 1979
  2. Descendant · cites it directly · 1 of its ownK951577 ES-3800, Video SigmoidoscopePentax Precision Instrument Corp. · 1996 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK964131 EndoscopeAkos Biomedical, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K951577ES-3800, Video SigmoidoscopePentax Precision Instrument Corp. · 1996 · cites it directly1descendant
  • K964131EndoscopeAkos Biomedical, Inc. · 1997 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K792341Pentax Flexible Sigmoidoscope Mod. FS-34Pentax Precision Instrument Corp.1979—
+1K951577ES-3800, Video SigmoidoscopePentax Precision Instrument Corp.19961
+2K964131EndoscopeAkos Biomedical, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
FIG. 1 — Lineage of K792341, 1979–1997Source: 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 FAM? 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
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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? (2)

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

NumberDeviceApplicantDecidedDescendants
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, K951577 (Pentax Precision Instrument Corp., 1996) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FAM devices

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

FDA decisions per year · FAM

FDA has decided no FAM device since 2007.

Median 510(k) review, days · FAM

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

Recalls per year · FAM

No recall names FAM since 2007.

Adverse event reports per year · FAM

3in 2025

2009: 22010: 22012: 32014: 12016: 32019: 22022: 32023: 42024: 112025: 3
2007high 11 (2024) · low 0 (2007)2025

MAUDE reports naming product code FAM, 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—00
20090—02
20100—02
20110—00
20120—03
20130—00
20140—01
20150—00
20160—03
20170—00
20180—00
20190—02
20200—00
20210—00
20220—03
20230—04
20240—011
20250—03
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 FAM

The FAM category page

  • K964131EndoscopeAkos Biomedical, Inc. · 1997
  • K970382VS-100 Video SigmoidoscopeWelch Allyn, Inc. · 1997
  • K964326Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath SystemVision-Sciences, Inc. · 1997
  • K964100Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic Sigmoidoscope and…Vision-Sciences, Inc. · 1996
  • K963344Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic SigmoidoscopeVision-Sciences, Inc. · 1996

https://510kreport.com/device/K792341 · printed Nov 4, 2026

Cite this page

510(k) Report. “K792341: Pentax Flexible Sigmoidoscope Mod. FS-34.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K792341

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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