510(k) · Cleared
ClearedVision Sciences Endosheath System
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 Jul 15, 2002 as substantially equivalent to K990354 (Vision-Sciences, Inc., 1999) after a 342-day review. Its family tree reaches back 3 generations to 1992. 157 later devices descend from it.
- Decided
- Jul 15, 2002
- Review
- 342 days
- Class
- Class II
- Product code
- EOB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K921244 (1992). 6 ancestors in all. 157 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 2 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 1 generation backK990354 EndosheathVision-Sciences, Inc. · 1999
- This deviceK012543 Vision Sciences Endosheath SystemVision-Sciences, Inc. · 2002
- Descendant · cites it directly · 92 of its ownK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- Descendant · 2 generations on · 70 of its ownK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
- Descendant · 3 generations on · 66 of its ownK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009
- Descendant · 4 generations on · 64 of its ownK130845 Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013
- Descendant · 5 generations on · 40 of its ownK161656 Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu…Ambu A/S · 2016
Showing 5 of 157 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 157 · See all- K031786Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003 · cites it directly92descendants
- K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc. · 2007 · 2 generations on70descendants
- K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc. · 2009 · 3 generations on66descendants
- K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013 · 4 generations on64descendants
- K161656Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8…Ambu A/S · 2016 · 5 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −2 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −1 | K990354 | Endosheath | Vision-Sciences, Inc. | 1999 | — |
| 0 (this device) | K012543 | Vision Sciences Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| +1 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| +2 | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and… | Vision-Sciences, Inc. | 2007 | — |
| +3 | K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System… | Vision-Sciences, Inc. | 2009 | — |
| +4 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
| +5 | K161656 | Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large… | Ambu A/S | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 9 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 5 | 0 |
| 2016 | 8 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 8 | 0 |
| 2021 | 9 | 0 |
| 2022 | 14 | 0 |
| 2023 | 13 | 0 |
| 2024 | 13 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 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 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? (3)
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 |
|---|---|---|---|
| * | K990354 | EndosheathSummary page 1…n is Class 11, Performance Standards 21 CFR 874.4760; 77EOB. Predicate Devices: Endosheath@ System for use with ENT Scopes (K990354) Manufactured and distributed by: Vision-Sciences, Inc.… | 1999 |
| * | — | Thermometer Covers Named without a submission number | |
| * | — | Transesophageal Ultrasound Probe Covers Named without a submission number |
What descends from it? (157)
See all 1574 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 10 years and passes through 1 company; a new generation was cleared every 3.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K031786 (Vision-Sciences, Inc., 2003) has gone furthest, with 92 descendants of its own.
- 11 other devices also cite its predicate K990354.
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 | — |
What is it indicated for?
The EndoSheathB System provides a sterile, disposable protective covering
for the scope to be used during flexible endoscopic examination of the upper
airway, vocal chords and/or nasal passages.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012543 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012543: Vision Sciences Endosheath System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012543
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026