510(k) · Cleared
ClearedPENTAX Medical Video Esophagoscope EE17-J10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · EOX Esophagoscope (Flexible Or Rigid)
Cleared on Dec 2, 2022 as substantially equivalent to K051972 (KARL STORZ Endoscopy-America, Inc., 2005) after a 63-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Dec 2, 2022
- Review
- 63 days
- Class
- Class II
- Product code
- EOX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921244 (1992). 14 ancestors in all. No later device cites it as a predicate yet.
- 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 backK051972 Karl Storz Trans-Nasal EsophagoscopeKARL STORZ Endoscopy-America, Inc. · 2005
- This deviceK223072 PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc. · 2022
View 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 | K051972 | Karl Storz Trans-Nasal Esophagoscope | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| 0 (this device) | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | Pentax of America, Inc. | 2022 | — |
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 |
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 |
|---|---|---|---|
| * | K051972 | Karl Storz Trans-Nasal EsophagoscopeSummary page 4…ification Panel Ear Nose & Throat 3 PREDICATE DEVICE The predicate device for this submission is Karl Storz Trans-Nasal Esophagoscope models 11301BN1and 11302BD1 (K051972). Both subject device and predicate device are used for variety of diagnostic and PENTA… | 2005 |
| † | K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 1 other device also cites its predicate K051972.
How does its category compare?
All EOX devicesEOX Esophagoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 PENTAX Medical Video Esophagoscope EE17-JI0 is intended to provide optical visualization of (via a video monitor), and therapeutic access to, the upper gastrointestinal tract. This anatomy includes the organs, tissues, and subsystems of esophagus and gastro-esophageal junction.
This endoscope is introduced via the mouth or nose when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223072: PENTAX Medical Video Esophagoscope EE17-J10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223072
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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