510(k) · Cleared
ClearedE.G. Scan (TM) Esophagoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intromedic Co., Ltd. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Oct 21, 2011 as substantially equivalent to K071903 (Vision-Sciences, Inc., 2007) and 3 other predicates after a 191-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Oct 21, 2011
- Review
- 191 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K921244 (1992). 18 ancestors in all. 2 later devices descend 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 backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 1 generation backK071903 Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc. · 2007
- This deviceK111030 E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011
- Descendant · cites it directly · 1 of its ownK120702 E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012
- Descendant · 2 generations on · 0 of its ownK131131 E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013
Most influential descendants
Showing 2 of 2 · See allView 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 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −1 | K071903 | Endosheath Systems for Use with Vision-Sciences Tne Scope | Vision-Sciences, Inc. | 2007 | — |
| 0 (this device) | K111030 | E.G. Scan (TM) Esophagoscope System | Intromedic Co., Ltd. | 2011 | — |
| +1 | K120702 | E.G. Scan II Esphagoscope System | Intromedic Co., Ltd. | 2012 | — |
| +2 | 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 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K071903 | Endosheath Systems for Use with Vision-Sciences Tne ScopeSummary page 1….Vision-Sciences, Inc. Device .EndoSheath® Systems for use with VSI Flexible Scope 510(k) Number :K071903 Manufacturer :Vision-Science, Inc. Device .Modified Flexible Trans-Nasal Es… | 2007 |
| * | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Summary page 1…h Digital Video Processor and Disposable EndoSheath® Systems 510(k) Number :K072088 IntroMedic Co., Ltd. 510(k) Submission - E.G. Scan Manufacturer Boston Scientific Co… | 2007 |
| * | K061787 | Maxforce TTS Single-Use Balloon DilatorSummary page 2…Manufacturer Boston Scientific Corporation Device :Maxforce TTS Single-Use Balloon Dilator 510(k) Number :K061 787 Manufacturer Fujion, Inc. Device :Fujinon Double Balloon Entermcopy System… | 2006 |
| * | K040048 | Fujinon Double Balloon Enteroscopy SystemSummary page 2…:K061 787 Manufacturer Fujion, Inc. Device :Fujinon Double Balloon Entermcopy System 510(k) Number .:K040048 4. Classifications Names & Citations: 21 CFR874.471 0, EOX, Esophagoscope System, Class2 5. Description: 5.1 Intr… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120702 | E.G. Scan II Esphagoscope System | 2012 | 1 |
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 19 years and passes through 2 companies; a new generation was cleared every 4.0 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K120702 (Intromedic Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 E.G. Scan TM Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111030: E.G. Scan (TM) Esophagoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111030
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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