510(k) · Cleared
ClearedDisposable Protective Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · EOB Nasopharyngoscope (Flexible Or Rigid)
Cleared on Oct 6, 1992 after a 204-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 187 later devices descend from it.
- Decided
- Oct 6, 1992
- Review
- 204 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 0
187 later devices descend from it, 4 citing it directly.
- This deviceK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- Descendant · cites it directly · 184 of its ownK950809 Vision-Sciences Disposable Endosheath for Flexible…Vision-Sciences, Inc. · 1996
- Descendant · cites it directly · 184 of its ownK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- Descendant · cites it directly · 180 of its ownK990354 EndosheathVision-Sciences, Inc. · 1999
- Descendant · 2 generations on · 158 of its ownK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- Descendant · 2 generations on · 157 of its ownK012543 Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002
Showing 5 of 187 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 187 · See all- K950809Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-LaryngoscopesVision-Sciences, Inc. · 1996 · cites it directly184descendants
- K961591Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996 · cites it directly184descendants
- K990354EndosheathVision-Sciences, Inc. · 1999 · cites it directly180descendants
- K963795Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable EndosheathVision-Sciences, Inc. · 1996 · 2 generations on158descendants
- K012543Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002 · 2 generations on157descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| +1 | K950809 | Vision-Sciences Disposable Endosheath for Flexible Nasopharyngo-Laryngoscopes | Vision-Sciences, Inc. | 1996 | — |
| +1 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| +1 | K990354 | Endosheath | Vision-Sciences, Inc. | 1999 | — |
| +2 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| +2 | K012543 | Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 5 | 0 |
| 2011 | 6 | 0 |
| 2012 | 10 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 11 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 9 | 0 |
| 2021 | 10 | 0 |
| 2022 | 16 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 13 | 0 |
| 2026 | 6 | 0 |
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 EOB? 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 EOB device
- #1 K253184 Video Rhinolaryngoscope System (Disposable…score 14.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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? (187)
See all 1874 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?
- Of its descendants, K950809 (Vision-Sciences, Inc., 1996) has gone furthest, with 184 descendants of its own.
How does its category compare?
All EOB devicesEOB Nasopharyngoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOB
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOB
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOB
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOB
1,338in 2025
MAUDE reports naming product code EOB, 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 | 37 | 0 | 1 |
| 2008 | 4 | 38 | 0 | 1 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 209 | 2 | 3 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 3 | 282 | 0 | 5 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 3 | 174 | 0 | 16 |
| 2017 | 6 | 216 | 0 | 18 |
| 2018 | 6 | 230 | 0 | 23 |
| 2019 | 8 | 149 | 0 | 51 |
| 2020 | 3 | 175 | 0 | 47 |
| 2021 | 2 | — | 0 | 345 |
| 2022 | 6 | 178 | 1 | 1,158 |
| 2023 | 3 | 107 | 1 | 1,352 |
| 2024 | 2 | — | 0 | 1,498 |
| 2025 | 3 | 192 | 0 | 1,338 |
| 2026 | 5 | 180 | 1 | — |
https://510kreport.com/device/K921244 · printed Nov 5, 2026
Cite this page
510(k) Report. “K921244: Disposable Protective Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K921244
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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