510(k) · Cleared

Cleared

Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic Sigmoidoscope and Vsi S-V100

K964100510(k) TraditionalCleared Dec 16, 199666-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 Dec 16, 1996 as substantially equivalent to K932843 (Vision-Sciences, Inc., 1994) and 4 other predicates after a 66-day review. Its family tree reaches back 2 generations to 1992.

Decided: Dec 16, 1996
Review: 66 days
Class: Class II
Product code: FAM
Recalls: None
Predicates: 5

Its longest line of descent runs back 2 generations to K921244 (1992). 8 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
1 generation backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
This deviceK964100 Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100…Vision-Sciences, Inc. · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K921244	Disposable Protective Sheath	Vision-Sciences, Inc.	1992	—
−1	K961591	Disposable Endosheath for E-F100 Flexible Nasopharyngoscope	Vision-Sciences, Inc.	1996	—
0 (this device)	K964100	Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible…	Vision-Sciences, Inc.	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1993	2	0
1994	1	0
1995	1	0
1996	1	0

FIG. 1 — Lineage of K964100, 1992–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (5)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K932843	Flexible Video Sigmoidoscope System W/Disp. Sheath Summary page 1 …metic Act, the device classification is Class II, Performance Standards (CFR 874.4760). Predicate Devices: S$S-V32 EndoSheath for use with the VSI S-V100 Sigmoidoscope (K932843) SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI C-F100 Colonoscope (K94389…	Vision-Sciences, Inc.	1994	—
*	K921690	Flexible Fiberoptic Sigmoidoscope System Summary page 1 …s (CFR 874.4760). Predicate Devices: S$S-V32 EndoSheath for use with the VSI S-V100 Sigmoidoscope (K932843) SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI C-F100 Colonoscope (K943895) EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591)…	Vision-Sciences, Inc.	1992	—
*	K943895	Vision System Colonscope Summary page 1 …use with the VSI S-V100 Sigmoidoscope (K932843) SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI C-F100 Colonoscope (K943895) EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591) EndoSheaths for use with Machida, Pentax and Olympus ENT Sco…	Vision-Sciences, Inc.	1995	—
*	K961591	Disposable Endosheath for E-F100 Flexible Nasopharyngoscope Summary page 1 …or use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI C-F100 Colonoscope (K943895) EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591) EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809) Manufactured and Distributed by: Vision-Sciences, In…	Vision-Sciences, Inc.	1996	—
*	K950809	Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes Our OCR of the scanned summary read K951809, FDA’s number for Gliding Nail (Encore Orthopedics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes”.	Vision-Sciences, Inc.	1996	—

Also cleared against K932843: 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 4 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
None of the 8 ancestors has a recall.
3 other devices also cite its predicate K932843.

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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	2
2010	—	2
2011	—	0
2012	—	3
2013	—	0
2014	—	1
2015	—	0
2016	—	3
2017	—	0
2018	—	0
2019	—	2
2020	—	0
2021	—	0
2022	—	3
2023	—	4
2024	—	11
2025	—	3
2026	—	—

What is it indicated for?

The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the sigmoid colon.

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/K964100 · printed Nov 6, 2026

Cite this page

510(k) Report. “K964100: Vision-Sciences Model SS-U32 Endo Sheath for Use with the Vsi S-F100 Flexible Fiberoptic Sigmoidoscope and Vsi S-V100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964100

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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