510(k) · Cleared
ClearedVision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · FAM Sigmoidoscope And Accessories, Flexible/Rigid
Cleared on Jan 3, 1997 as substantially equivalent to K932843 (Vision-Sciences, Inc., 1994) after a 65-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 3, 1997
- Review
- 65 days
- Class
- Class II
- Product code
- FAM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932843 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK932843 Flexible Video Sigmoidoscope System W/Disp. SheathVision-Sciences, Inc. · 1994
- This deviceK964326 Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope…Vision-Sciences, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932843 | Flexible Video Sigmoidoscope System W/Disp. Sheath | Vision-Sciences, Inc. | 1994 | — |
| 0 (this device) | K964326 | Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with… | Vision-Sciences, Inc. | 1997 | — |
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.
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
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K932843 | Flexible Video Sigmoidoscope System W/Disp. SheathSummary page 1…classification is Class 1]. Performance Standards (CFR 876.1500). Predicate Devices: I. Vision-Sciences Model S-V100 Video Sigmoidoscope with SS-V32 EndoSheath System (K932843) Manufactured and Distributed by: Vision-Sciences, Inc. 6 Strathmore Rd. Natick. MA 01760 2. Mode! VS-200 Video Sigmoidoscope… | 1994 |
| Kept off the family tree | K954704 | FDA’s K954704 is VS-200 Video Sigmoidoscope Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1996 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K932843.
How does its category compare?
All FAM devicesFAM 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
MAUDE reports naming product code FAM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The proposed VSI Model S-V200 Color Video Sigmoidoscope is intended for use to examine the lower bowel tract, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964326: Vision-Sciences Model S-V200 Color Mvideo Flexible Sigmoidoscope with Endosheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964326
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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