510(k) · Cleared
ClearedEndosheath Systems for Use with Vision-Sciences Tne Scope
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 2, 2007 as substantially equivalent to K031786 (Vision-Sciences, Inc., 2003) after a 23-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it.
- Decided
- Aug 2, 2007
- Review
- 23 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K921244 (1992). 12 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 4 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 3 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 2 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 1 generation backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- This deviceK071903 Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK111030 E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011
- Descendant · 2 generations on · 1 of its ownK120702 E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012
- Descendant · 3 generations on · 0 of its ownK131131 E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013
Most influential descendants
Showing 3 of 3 · See all- K111030E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011 · cites it directly2descendants
- K120702E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012 · 2 generations on1descendant
- K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −4 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −3 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −2 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −1 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| 0 (this device) | K071903 | Endosheath Systems for Use with Vision-Sciences Tne Scope | Vision-Sciences, Inc. | 2007 | — |
| +1 | K111030 | E.G. Scan (TM) Esophagoscope System | Intromedic Co., Ltd. | 2011 | — |
| +2 | K120702 | E.G. Scan II Esphagoscope System | Intromedic Co., Ltd. | 2012 | — |
| +3 | K131131 | E.G. Scan (TM) II Esophagoscope System | Intromedic Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 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? (1)
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 |
|---|---|---|---|
| * | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath SystemSummary page 1…EOX FDA Regulations: 21 CFR 874.47 10 Device Classification: Class II Premarket Notification: K03 1786 Device Description The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working chan… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111030 | E.G. Scan (TM) Esophagoscope System | 2011 | 2 |
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 15 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K111030 (Intromedic Co., Ltd., 2011) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K031786.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 flexible trans-nasal esophagoscope with EndoSheath® System is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071903 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071903: Endosheath Systems for Use with Vision-Sciences Tne Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071903
Report an extraction error
Are you the manufacturer?
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