510(k) · Cleared
ClearedE.G. Scan II Esphagoscope 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 Jun 20, 2012 as substantially equivalent to K111030 (Intromedic Co., Ltd., 2011) and 1 other predicate after a 104-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- Jun 20, 2012
- Review
- 104 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K921244 (1992). 19 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK921244 Disposable Protective SheathVision-Sciences, Inc. · 1992
- 6 generations backK961591 Disposable Endosheath for E-F100 Flexible NasopharyngoscopeVision-Sciences, Inc. · 1996
- 5 generations backK963795 Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21…Vision-Sciences, Inc. · 1996
- 4 generations backK021344 B-F200 Bronchoscope with BSS-F21 Endosheath SystemVision-Sciences, Inc. · 2002
- 3 generations backK031786 Tne-2000 Esophagoscope with Ecs-D Endosheath SystemVision-Sciences, Inc. · 2003
- 2 generations backK071903 Endosheath Systems for Use with Vision-Sciences Tne ScopeVision-Sciences, Inc. · 2007
- 1 generation backK111030 E.G. Scan (TM) Esophagoscope SystemIntromedic Co., Ltd. · 2011
- This deviceK120702 E.G. Scan II Esphagoscope SystemIntromedic Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK131131 E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131131E.G. Scan (TM) II Esophagoscope SystemIntromedic Co., Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K921244 | Disposable Protective Sheath | Vision-Sciences, Inc. | 1992 | — |
| −6 | K961591 | Disposable Endosheath for E-F100 Flexible Nasopharyngoscope | Vision-Sciences, Inc. | 1996 | — |
| −5 | K963795 | Vision-Sciences Model B-F100 Bronchoscope with Model BS-F21 Disposable… | Vision-Sciences, Inc. | 1996 | — |
| −4 | K021344 | B-F200 Bronchoscope with BSS-F21 Endosheath System | Vision-Sciences, Inc. | 2002 | — |
| −3 | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath System | Vision-Sciences, Inc. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | K120702 | E.G. Scan II Esphagoscope System | Intromedic Co., Ltd. | 2012 | — |
| +1 | 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 |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K111030 | E.G. Scan (TM) Esophagoscope SystemSummary page 1…redicate Device: Manufacturer :IntroMedic Co., Ltd, Device :E.G. Scanwm Esophagoscope System 510(k) Number :K1 11030 Manufacturer :Vision-Science, Inc. Device :Modified Flexible Trans-Nasal Esophagosco… | 2011 |
| * | K072088 | Flexible Trans-Nasal Video Esophagoscope with Digital Video Processor and Disposable…Summary page 1…goscope with Digital Video Processor and Disposable Endoheath& System 510(k) Number : K072088 4. Classifications Names & Citations 21 CFR874.471 0, EOX, Esophagoscope System, Ciass2 IntroMedic Co., Ltd.… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131131 | E.G. Scan (TM) II Esophagoscope System | 2013 | 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 20 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K131131 (Intromedic Co., Ltd., 2013) has gone furthest, with 0 descendants 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. 2012, 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?
E.G. Scan 11 Esophagoscope System is intended for use in endoscopic access and examination of the larynx, esophagus and gastroesophageal junction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120702: E.G. Scan II Esphagoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120702
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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