510(k) · Cleared
ClearedTne-2000 Esophagoscope with Ecs-D Endosheath System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision-Sciences, Inc. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Aug 5, 2003 as substantially equivalent to K990354 (Vision-Sciences, Inc., 1999) and 2 other predicates after a 56-day review. Its family tree reaches back 4 generations to 1992. 92 later devices descend from it.
- Decided
- Aug 5, 2003
- Review
- 56 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K921244 (1992). 11 ancestors in all. 92 later devices descend from it, 8 citing it directly.
- Root · 4 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 3 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 2 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 1 generation backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- This deviceK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- Descendant · cites it directly · 70 of its ownK072088 Flexible Trans-Nasal Video Esophagoscope with Digital Video…Vision-Sciences, Inc. · 2007
- Descendant · 2 generations on · 66 of its ownK091768 Video Sciences BRS-5000 Video Bronchoscope with Endosheath System…Vision-Sciences, Inc. · 2009
- Descendant · 3 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 · 4 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
- Descendant · 5 generations on · 39 of its ownK173727 Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2…Ambu A/S · 2018
Showing 5 of 92 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 92 · See all- K072088Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Vision-Sciences, Inc. · 2007 · cites it directly70descendants
- K091768Video Sciences BRS-5000 Video Bronchoscope with Endosheath System, Dpu-5000/Dpu-5050…Vision-Sciences, Inc. · 2009 · 2 generations on66descendants
- K130845Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu AviewAmbu A/S · 2013 · 3 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 · 4 generations on40descendants
- K173727Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular…Ambu A/S · 2018 · 5 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −3 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −2 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −1 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| 0 (this device) | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| +1 | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and… | Vision-Sciences, Inc. | 2007 | — |
| +2 | K091768 | Video Sciences BRS-5000 Video Bronchoscope with Endosheath System… | Vision-Sciences, Inc. | 2009 | — |
| +3 | K130845 | Ambu Ascope 3 5.0/2.2; Ambu Ascope 3 Slim 3.8/1.2; Ambu Aview | Ambu A/S | 2013 | — |
| +4 | 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 | — |
| +5 | K173727 | Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope… | Ambu A/S | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 8 | 0 |
| 2022 | 12 | 0 |
| 2023 | 10 | 0 |
| 2024 | 12 | 0 |
| 2025 | 12 | 0 |
| 2026 | 5 | 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 EOX? 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 EOX device
- #1 K222366 EsoCheck Cell Collection Devicescore 7.8 · 3 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…According to Section 5 13 of the Federal Food, Drug, and Cosmetic Act, the device classification is Class 11. Predicate Devices: K990354 - Slide-On Endosheath@ for Flexible ENT Scopes KO12543 - Endosheath@ System for Flexible ENT Scopes… | 1999 |
| * | K012543 | Vision Sciences Endosheath System | 2002 |
| * | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | 2002 |
What descends from it? (92)
See all 928 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable… | 2007 | 70 |
| K040215 | Vision-Sciences CST-2000 Flexible Cystoscope with Slide-on Endosheath System | 2004 | 26 |
| K053560 | Modified Endosheath System for Vsi Flexible Cystoscope | 2006 | 23 |
| K082569 | Entellus Medical Flexible Endoscope and Eyepiece | 2008 | 5 |
| K071903 | Endosheath Systems for Use with Vision-Sciences Tne Scope | 2007 | 3 |
| K051972 | Karl Storz Trans-Nasal Esophagoscope | 2005 | 2 |
| K061663 | Endomedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath for… | 2006 | 0 |
| K061324 | Emt Quik-Cover Flexible Endoscope Barrier Sheath, Series 1-7 | 2006 | 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 11 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K072088 (Vision-Sciences, Inc., 2007) has gone furthest, with 70 descendants of its own.
- 11 other devices also cite its predicate K990354.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EOX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EOX
Too few EOX 510(k)s in any year since 2007 to give a median.
Recalls per year · EOX
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EOX
2in 2024
MAUDE reports naming product code EOX, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 2 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 2 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 12 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vision-Sciences Trans-Nasal Esophagoscope with Endosheath® System is indicated for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The System may also be used to assist intubation.
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/K031786 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031786: Tne-2000 Esophagoscope with Ecs-D 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/K031786
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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