510(k) · Cleared
ClearedColonoscope/Sigmoidoscope Sheathes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sheathing Technologies, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Aug 3, 2010 as substantially equivalent to K081004 (Stryker GI, 2008) and 1 other predicate after a 117-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Aug 3, 2010
- Review
- 117 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K921244 (1992). 22 ancestors in all, the oldest K822846 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 5 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 4 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 3 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 2 generations backK032688 Colonosight Model 510BSightline Technologies, Ltd. · 2004
- 1 generation backK081004 Protectiscope CS Colonoscope, Non-IntrapullStryker GI · 2008
- This deviceK100966 Colonoscope/Sigmoidoscope SheathesSheathing Technologies, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK183171 ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K183171ScopeSeal Duodenoscope Protective DeviceGi Scientific, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −5 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −4 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −3 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −2 | K032688 | Colonosight Model 510B | Sightline Technologies, Ltd. | 2004 | — |
| −1 | K081004 | Protectiscope CS Colonoscope, Non-Intrapull | Stryker GI | 2008 | — |
| 0 (this device) | K100966 | Colonoscope/Sigmoidoscope Sheathes | Sheathing Technologies, Inc. | 2010 | — |
| +1 | K183171 | ScopeSeal Duodenoscope Protective Device | Gi Scientific, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 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 FDF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081004 | Protectiscope CS Colonoscope, Non-Intrapull Our reading of the summary gave K051004, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ProtectiScope colonoscope Sheath”. | 2008 |
| * | K032688 | Colonosight Model 510BSummary page 2…moidoscope Accessory Equivalence: 510O(K) K051004, ProtectiScope CS, Stryker GI (disposable sheath only) 510O(K) K032688, Colonosight Model 51lOB, Sightline Technologies (disposable sheath only) Labelin… | 2004 |
| † | K963831 | Sheathes (Non-Latex) | 1997 |
| † | K990175 | Sheathes (Non-Latex), Sterile | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183171 | ScopeSeal Duodenoscope Protective Device | 2019 | 0 |
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 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 22 ancestors have a recall of any class.
- Of its descendants, K183171 (Gi Scientific, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K081004.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
Colonoscope/Sigmoidoscope Sheaths are meant for use in non-sterile colonoscopy or sigmoidoscopy procedures to help reduce gross contamination of the endoscope, reducing the exposure of staff to gross contamination during the cleaning procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100966: Colonoscope/Sigmoidoscope Sheathes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100966
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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