510(k) Report

510(k) · Cleared

Cleared

Flexible Video Sigmoidoscope System W/Disp. Sheath

K932843510(k) TraditionalCleared Feb 14, 1994248-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

Vision-Sciences, Inc. · FAM Sigmoidoscope And Accessories, Flexible/Rigid

Cleared on Feb 14, 1994 after a 248-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 162 later devices descend from it.

Decided
Feb 14, 1994
Review
248 days
Class
Class II
Product code
FAM
Recalls
None
Predicates
0

162 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1996: 2 descendants cleared1997: 2 descendants cleared2002: 1 descendant cleared2003: 3 descendants cleared2006: 4 descendants cleared2004: 2 descendants cleared2009: 4 descendants cleared2007: 6 descendants cleared2005: 1 descendant cleared2008: 3 descendants cleared2010: 4 descendants cleared2012: 9 descendants cleared2018: 5 descendants cleared2013: 5 descendants cleared2022: 14 descendants cleared2020: 8 descendants cleared2015: 5 descendants cleared2017: 5 descendants cleared2026: 6 descendants cleared2011: 5 descendants cleared2016: 8 descendants cleared2014: 7 descendants cleared2019: 6 descendants cleared2021: 9 descendants cleared2023: 13 descendants cleared2024: 13 descendants cleared2025: 12 descendants cleared1990200020102020
  1. This deviceK932843 Flexible Video Sigmoidoscope System W/Disp. SheathVision-Sciences, Inc. · 1994
  2. Descendant · cites it directly · 158 of its ownK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
  3. Descendant · 2 generations on · 157 of its ownK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
  4. Descendant · 3 generations on · 92 of its ownK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
  5. Descendant · 4 generations on · 70 of its ownK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
  6. Descendant · 3 generations on · 66 of its ownK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009

Showing 5 of 162 descendants. See all descendants

Descendants cleared per year

1996: 21997: 22002: 12003: 32004: 22005: 12006: 42007: 62008: 32009: 42010: 42011: 52012: 92013: 52014: 72015: 52016: 82017: 52018: 52019: 62020: 82021: 92022: 142023: 132024: 132025: 122026: 6
1996high 14 (2022) · low 0 (1998)2026

Most influential descendants

Showing 5 of 162 · See all
  • K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc. · 1996 · cites it directly158descendants
  • K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002 · 2 generations on157descendants
  • K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003 · 3 generations on92descendants
  • K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc. · 2007 · 4 generations on70descendants
  • K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc. · 2009 · 3 generations on66descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932843Flexible Video Sigmoidoscope System W/Disp. SheathVision-Sciences, Inc.1994—
+1K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable…Vision-Sciences, Inc.1996—
+2K021344B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc.2002—
+3K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc.2003—
+4K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and…Vision-Sciences, Inc.2007—
+3K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199720
200210
200330
200420
200510
200640
200760
200830
200940
201040
201150
201290
201350
201470
201550
201680
201750
201850
201960
202080
202190
2022140
2023130
2024130
2025120
202660
FIG. 1 — Lineage of K932843, 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 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (162)

See all 162

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc.1996158
K964131EndoscopeAkos Biomedical, Inc.19970
K964326Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath SystemVision-Sciences, Inc.19970
K964100Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic…Vision-Sciences, Inc.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, K963795 (Vision-Sciences, Inc., 1996) has gone furthest, with 158 descendants 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 Vision-Sciences, Inc.

33 FDA decisions under this applicant name. See the company

  • K102733Vision-Sciences Ent-5000 Video Ent Scope with Endosheath Technology, Vision-Sciences Dpu-5000/Dpu-5050 Video…Vision-Sciences, Inc. · 2011
  • K100125Vision Sciences Flexible Ent ScopeVision-Sciences, Inc. · 20102 recalls
  • K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050 Video Processor &…Vision-Sciences, Inc. · 2009
  • K072180Vision-Sciences CST-5000 Video Cystoscope with Endosheath SystemVision-Sciences, Inc. · 2007
  • K071127Flexible Hysteroscope with Endosheath SystemVision-Sciences, Inc. · 2007

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/K932843 · printed Nov 5, 2026

Cite this page

510(k) Report. “K932843: Flexible Video Sigmoidoscope System W/Disp. Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K932843

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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