510(k) · Cleared
ClearedDisposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope
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 Nov 21, 1996 as substantially equivalent to K921690 (Vision-Sciences, Inc., 1992) and 3 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Nov 21, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- FAM
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K921244 (1992). 7 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 1 generation backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- This deviceK963344 Disposable SS-F32 Endosheath for Use with the S-F100 Flexible…Vision-Sciences, Inc. · 1996
- Descendant · cites it directly · 0 of its ownK061663 Endomedical Technologies Quik-Cover Flexible Endoscope Barrier…Rtc Inc.-Memcath Technologies, LLC · 2006
- Descendant · cites it directly · 0 of its ownK061324 Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7Rtc Inc.-Memcath Technologies, LLC · 2006
Most influential descendants
Showing 2 of 2 · See allView 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) | K963344 | Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic… | Vision-Sciences, Inc. | 1996 | — |
| +1 | K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for… | Rtc Inc.-Memcath Technologies, LLC | 2006 | — |
| +1 | K061324 | Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 | Rtc Inc.-Memcath Technologies, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
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? (4)
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 | Decided |
|---|---|---|---|
| * | K921690 | Flexible Fiberoptic Sigmoidoscope SystemSummary page 1…metic Act, the device classification is Class II, Performance Standards (CFR 874.4760). Predicate Devices: SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591) EndoSheath for Use with the VSI C-F100 Colonoscope (K943895)… | 1992 |
| * | K961591 | Disposable Endosheath for E-F100 Flexible NasopharyngoscopeSummary page 1…ards (CFR 874.4760). Predicate Devices: SS-F32 EndoSheath for use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591) EndoSheath for Use with the VSI C-F100 Colonoscope (K943895) EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K9… | 1996 |
| * | K943895 | Vision System ColonscopeSummary page 1…or use with the VSI S-F100 Sigmoidoscope (K921690) EndoSheath for use with the VSI E-F100 Nasopharyngoscope (K961591) EndoSheath for Use with the VSI C-F100 Colonoscope (K943895) EndoSheaths for use with Machida, Pentax and Olympus ENT Scopes (K951809) Manufactured and Distributed by: Vision-Sciences, Inc… | 1995 |
| * | 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”. | 1996 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 7 ancestors has a recall.
- Of its descendants, K061663 (Rtc Inc.-Memcath Technologies, LLC, 2006) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K921690.
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 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/K963344 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963344: Disposable SS-F32 Endosheath for Use with the S-F100 Flexible Fiberoptic Sigmoidoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963344
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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