510(k) · Cleared
Recalled · 2026PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax of America, Inc. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Jul 23, 2020 as substantially equivalent to K182004 (Pentax of America, Inc., 2018) after a 189-day review. Its family tree reaches back 9 generations to 1981. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 23, 2020
- Review
- 189 days
- Class
- Class II
- Product code
- ODG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K812810 (1981). 16 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 5 generations between
- 3 generations backK130247 Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · Recalled
- 2 generations backK162447 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I.…Pentax of America, Inc. · 2017
- 1 generation backK182004 PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc. · 2018 · Recalled
- This deviceK200090 PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U…Pentax of America, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK232518 EndoSound Vision System; EVSEndosound, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK203166 PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX…Pentax of America, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 8 generations backK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
- 7 generations backK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
- 6 generations backK021278 EG-3630UR, Ultrasound Video GastroscopePentax Precision Instrument Corp. · 2002
- 5 generations backK023401 EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
- 4 generations backK090197 EG-3870UTKPentax Medical Company · 2009 · Recalled
- 3 generations backK130247 Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · Recalled
- 2 generations backK162447 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I.…Pentax of America, Inc. · 2017
- 1 generation backK182004 PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc. · 2018 · Recalled
- This deviceK200090 PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U…Pentax of America, Inc. · 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 |
|---|---|---|---|---|---|
| −9 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| −8 | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | 2 |
| −7 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
| −6 | K021278 | EG-3630UR, Ultrasound Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| −5 | K023401 | EG-3830UT, Video Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2003 | — |
| −4 | K090197 | EG-3870UTK | Pentax Medical Company | 2009 | 2 |
| −3 | K130247 | Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | 1 |
| −2 | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope… | Pentax of America, Inc. | 2017 | — |
| −1 | K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | 2018 | 2 |
| 0 (this device) | K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound… | Pentax of America, Inc. | 2020 | — |
| +1 | K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023 | — |
| +1 | K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical… | Pentax of America, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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 ODG? 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 ODG device
- #1 K251859 EVIS EUS Ultrasound Gastrointestinal…score 14.0 · 4 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 |
|---|---|---|---|
| * | K182004 | PENTAX Medical Endoscopic Ultrasound SystemSummary page 4…art 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Codes: ODG, ITX Predicate Device: PENTAX Medical Endoscopic Ultrasound System (K182004) PENTAX Medical is seeking clearance of a new line of ultrasound upper GI video scopes EG- J10U with the Pentax Video Processors… | 2018 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2026 | Not classified | Z-0306-2027 | Unknown/Undetermined by firm | Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. |
| Sep 9, 2026 | Not classified | Z-0307-2027 | Unknown/Undetermined by firm | Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 39 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 5 of the 16 ancestors have a recall of any class.
- Of its descendants, K232518 (Endosound, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ODG devicesODG Endoscopic Ultrasound System, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · ODG
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODG
71in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODG
4in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODG
3,569in 2025
MAUDE reports naming product code ODG, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 2 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 1 | — | 0 | 50 |
| 2017 | 4 | 75 | 0 | 82 |
| 2018 | 3 | 30 | 0 | 66 |
| 2019 | 1 | — | 0 | 96 |
| 2020 | 2 | — | 4 | 445 |
| 2021 | 1 | — | 0 | 1,234 |
| 2022 | 4 | 71 | 0 | 1,832 |
| 2023 | 1 | — | 0 | 2,078 |
| 2024 | 1 | — | 0 | 1,904 |
| 2025 | 2 | — | 0 | 3,569 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The PENTAX Medical EG-J10U Endoscopic Ultrasound System is intended to provide
optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper
Gastrointestinal Tract including but not restricted to the organs, tissues, and
subsystems: Esophagus, Stomach, Duodenum and underlying areas. The instrument is
introduced per orally when indications consistent with the requirement for procedure
are observed in adult and pediatric patient populations.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200090 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200090: PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200090
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