510(k) Report

510(k) · Cleared

Cleared

Endoscope

K964131510(k) TraditionalCleared Jun 27, 1997255-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

Akos Biomedical, Inc. · FAM Sigmoidoscope And Accessories, Flexible/Rigid

Cleared on Jun 27, 1997 as substantially equivalent to K853585 (Olympus Corp., 1986) and 13 other predicates after a 255-day review. Its family tree reaches back 2 generations to 1979.

Decided
Jun 27, 1997
Review
255 days
Class
Class II
Product code
FAM
Recalls
None
Predicates
14

Its longest line of descent runs back 2 generations to K792341 (1979). 18 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 3 other ancestors1995: 3 other ancestors1994: 4 other ancestors1993: 1 other ancestor1992: 2 other ancestors1986: 1 other ancestor1980: 1 other ancestor1982: 1 other ancestorK792341 · Pentax Flexible Sigmoidoscope Mod. FS-34 · Pentax Precision Instrument Corp. · 1979K951577 · ES-3800, Video Sigmoidoscope · Pentax Precision Instrument Corp. · 1996 · recalled19751980198519901995
Other ancestors, by generation 1 generation back: 13 other ancestors2 generations back: 3 other ancestors K951577 · ES-3800, Video Sigmoidoscope · Pentax Precision Instrument Corp. · 1996 · recalledK792341 · Pentax Flexible Sigmoidoscope Mod. FS-34 · Pentax Precision Instrument Corp. · 19790
  1. Root · 2 generations backK792341 Pentax Flexible Sigmoidoscope Mod. FS-34Pentax Precision Instrument Corp. · 1979
  2. 1 generation backK951577 ES-3800, Video SigmoidoscopePentax Precision Instrument Corp. · 1996 · Recalled
  3. This deviceK964131 EndoscopeAkos Biomedical, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

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

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198210
198610
199220
199310
199440
199530
199630
FIG. 1 — Lineage of K964131, 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), 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.

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  • 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? (14)

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
*K853585Olympus Evs-Endoscopic Video Image & Data Sys
Summary page 1
…ertion tube advances through the colon. Predicate Device 510(k) Information: Company Name 510 (k) No. 510(k) Description per CDRH Electronic Docket Olympus Corporation K853585 Olympus EVS-Endoscopic Video Image & Data Sys. Pentax Precision Inst. K951576 FS-34P2, Fiber Sigmoidoscope K951577 ES-3800, Video…
Olympus Corp.19862
*K951576FS-34P2, Fiber Sigmoidoscope
Summary page 1
…Company Name 510 (k) No. 510(k) Description per CDRH Electronic Docket Olympus Corporation K853585 Olympus EVS-Endoscopic Video Image & Data Sys. Pentax Precision Inst. K951576 FS-34P2, Fiber Sigmoidoscope K951577 ES-3800, Video Sigmoidoscope K951579 EC-3800TL, Video Colonoscope K951574 EC-3800L, Video Co…
Pentax Precision Instrument Corp.1995—
*K951577ES-3800, Video Sigmoidoscope
Summary page 1
…ription per CDRH Electronic Docket Olympus Corporation K853585 Olympus EVS-Endoscopic Video Image & Data Sys. Pentax Precision Inst. K951576 FS-34P2, Fiber Sigmoidoscope K951577 ES-3800, Video Sigmoidoscope K951579 EC-3800TL, Video Colonoscope K951574 EC-3800L, Video Colonoscope Vision Sciences, Inc. K9328…
Pentax Precision Instrument Corp.19961
*K951579EC-3800TL, Video Colonoscope
Summary page 1
…ympus Corporation K853585 Olympus EVS-Endoscopic Video Image & Data Sys. Pentax Precision Inst. K951576 FS-34P2, Fiber Sigmoidoscope K951577 ES-3800, Video Sigmoidoscope K951579 EC-3800TL, Video Colonoscope K951574 EC-3800L, Video Colonoscope Vision Sciences, Inc. K932843 Flexible Video Sigmoidoscope Syste…
Pentax Precision Instrument Corp.19961
*K951574EC-3800L, Video Colonoscope
Summary page 1
…-Endoscopic Video Image & Data Sys. Pentax Precision Inst. K951576 FS-34P2, Fiber Sigmoidoscope K951577 ES-3800, Video Sigmoidoscope K951579 EC-3800TL, Video Colonoscope K951574 EC-3800L, Video Colonoscope Vision Sciences, Inc. K932843 Flexible Video Sigmoidoscope System w/Disp. Sheath K933247 Protective S…
Pentax Precision Instrument Corp.19963
*K932843Flexible Video Sigmoidoscope System W/Disp. Sheath
Summary page 1
…K951576 FS-34P2, Fiber Sigmoidoscope K951577 ES-3800, Video Sigmoidoscope K951579 EC-3800TL, Video Colonoscope K951574 EC-3800L, Video Colonoscope Vision Sciences, Inc. K932843 Flexible Video Sigmoidoscope System w/Disp. Sheath K933247 Protective Sheath - Flexible Nasopharyngo-Larygnoscope K921690 Flexibl…
Vision-Sciences, Inc.1994—
*K933247Protective Sheath for Flexible Nasophary/Larygnos
Summary page 1
…o Sigmoidoscope K951579 EC-3800TL, Video Colonoscope K951574 EC-3800L, Video Colonoscope Vision Sciences, Inc. K932843 Flexible Video Sigmoidoscope System w/Disp. Sheath K933247 Protective Sheath - Flexible Nasopharyngo-Larygnoscope K921690 Flexible Fiberoptic Sigmoidoscope System K921244 Disposable Protec…
Vision-Sciences, Inc.1993—
*K921690Flexible Fiberoptic Sigmoidoscope System
Summary page 1
…-3800L, Video Colonoscope Vision Sciences, Inc. K932843 Flexible Video Sigmoidoscope System w/Disp. Sheath K933247 Protective Sheath - Flexible Nasopharyngo-Larygnoscope K921690 Flexible Fiberoptic Sigmoidoscope System K921244 Disposable Protective Sheath Fuyjinon, Inc. K944759 200 Series Gastro-Intestina…
Vision-Sciences, Inc.1992—
*K921244Disposable Protective Sheath
Summary page 1
…932843 Flexible Video Sigmoidoscope System w/Disp. Sheath K933247 Protective Sheath - Flexible Nasopharyngo-Larygnoscope K921690 Flexible Fiberoptic Sigmoidoscope System K921244 Disposable Protective Sheath Fuyjinon, Inc. K944759 200 Series Gastro-Intestinal Video System K933906 Choledochoscope/Endoscope…
Vision-Sciences, Inc.1992—
*K944759200 Series Gastro-Intestinal Video System
Summary page 1
…eath K933247 Protective Sheath - Flexible Nasopharyngo-Larygnoscope K921690 Flexible Fiberoptic Sigmoidoscope System K921244 Disposable Protective Sheath Fuyjinon, Inc. K944759 200 Series Gastro-Intestinal Video System K933906 Choledochoscope/Endoscope Modification Welch Allyn, Inc. K954704 VS-200 Video S…
Fujinon, Inc.19955
*K933906Choledochoscope/Endoscope Modification
Summary page 1
…yngo-Larygnoscope K921690 Flexible Fiberoptic Sigmoidoscope System K921244 Disposable Protective Sheath Fuyjinon, Inc. K944759 200 Series Gastro-Intestinal Video System K933906 Choledochoscope/Endoscope Modification Welch Allyn, Inc. K954704 VS-200 Video Sigmoidoscope K950429 Video Sigmoidoscope K801247…
Fujinon, Inc.1994—
*K954704VS-200 Video Sigmoidoscope
Summary page 1
…m K921244 Disposable Protective Sheath Fuyjinon, Inc. K944759 200 Series Gastro-Intestinal Video System K933906 Choledochoscope/Endoscope Modification Welch Allyn, Inc. K954704 VS-200 Video Sigmoidoscope K950429 Video Sigmoidoscope K801247 CCD Endoscope 1 M43 2 Sterilization: CLRIEL Pra…
Welch Allyn, Inc.1996—
*K950429Video Sigmoidoscope
Summary page 1
…th Fuyjinon, Inc. K944759 200 Series Gastro-Intestinal Video System K933906 Choledochoscope/Endoscope Modification Welch Allyn, Inc. K954704 VS-200 Video Sigmoidoscope K950429 Video Sigmoidoscope K801247 CCD Endoscope 1 M43 2 Sterilization: CLRIEL Pra) 3 The Disposable Assembly will be…
Welch Allyn, Inc.1995—
*K801247CCD Endoscope and Attachments
Summary page 1
…00 Series Gastro-Intestinal Video System K933906 Choledochoscope/Endoscope Modification Welch Allyn, Inc. K954704 VS-200 Video Sigmoidoscope K950429 Video Sigmoidoscope K801247 CCD Endoscope 1 M43 2 Sterilization: CLRIEL Pra) 3 The Disposable Assembly will be marketed as “Sterile” - “Co…
Welch Allyn, Inc.1980—

Also cleared against K853585: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 16.3 years on median.
  • 5 of the 18 ancestors have a recall of any class.
  • 3 other devices also cite its predicate K853585.

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—

What is it indicated for?

The akos endoscope system is used to examine body cavities, -hollow organs and canals, specifically the lower Gl tract (colon) only, and, using additional accessories, to perform various diagnostic and therapeutic praocedures.

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 K853585

3 other devices cite the same predicate.

  • K070330Third Eye Retroscope Auxiliary Endoscopy SystemAvantis Medical Systems, Inc. · 2007
  • K024033XTJF-160AF DuodenovideoscopeOlympus Optical Co., Ltd. · 20021 recall
  • K954451Evis 140 SystemOlympus America, Inc. · 19963 recalls

Recent decisions in FAM

The FAM category page

  • 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
  • K961567ES-3840, Video SigmoidoscopePentax Precision Instrument Corp. · 1996

https://510kreport.com/device/K964131 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964131: Endoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964131

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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