510(k) · Cleared
ClearedKarl Storz Trans-Nasal Esophagoscope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Aug 15, 2005 as substantially equivalent to K981458 (Karl Storz Endoscopy, 1998) and 1 other predicate after a 25-day review. Its family tree reaches back 5 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 15, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K921244 (1992). 13 ancestors in all. 2 later devices descend from it, 2 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 deviceK051972 Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK223072 PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK192523 CMOS Video Esophagoscope SSUKarl Storz SE & CO. KG · 2020
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 |
|---|---|---|---|---|---|
| −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) | K051972 | Karl Storz Trans-Nasal Esophagoscope | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| +1 | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022 | — |
| +1 | K192523 | CMOS Video Esophagoscope SSU | Karl Storz SE & CO. KG | 2020 | — |
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 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K981458 | Ksea Rhino-Laryngo-Broncho-Fiberscope,Pediatric Broncho-Fiberscope, and…Summary page 1…or differences between the Karl Storz Trans-Nasal uses Esophagoscopes and the KSEA Rhino-Laryngo-Broncho-Fiberscope and Broncho- Fiberscope (K981458), and the TNE-2000 marketed by Vision Sciences, Inc. (K031786) raise no new issues of safety and effectiveness, as these des… | 1998 |
| * | K031786 | Tne-2000 Esophagoscope with Ecs-D Endosheath SystemSummary page 1…uses Esophagoscopes and the KSEA Rhino-Laryngo-Broncho-Fiberscope and Broncho- Fiberscope (K981458), and the TNE-2000 marketed by Vision Sciences, Inc. (K031786) raise no new issues of safety and effectiveness, as these design differences have… | 2003 |
What descends from it? (2)
2 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 13 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K223072 (Pentax of America, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981458.
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 Karl Storz Trans-Nasal Esophagoscopes are designed to be used by qualified surgeons and physicians and are indicated for endoscopic access and examination of the nasal sinuses, larynx, esophagus and gastro-esophageal junction and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051972: Karl Storz Trans-Nasal Esophagoscope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051972
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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