510(k) · Cleared
Recalled · 2026PENTAX Medical Endoscopic Ultrasound System
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 Aug 21, 2018 as substantially equivalent to K162447 (Pentax of America, Inc., 2017) after a 25-day review. Its family tree reaches back 8 generations to 1981. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 21, 2018
- Review
- 25 days
- Class
- Class II
- Product code
- ODG
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 8 generations to K812810 (1981). 15 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 7 generations backK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
- 6 generations backK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
- 5 generations backK021278 EG-3630UR, Ultrasound Video GastroscopePentax Precision Instrument Corp. · 2002
- 4 generations backK023401 EG-3830UT, Video Ultrasound GastroscopePentax Precision Instrument Corp. · 2003
- 3 generations backK090197 EG-3870UTKPentax Medical Company · 2009 · Recalled
- 2 generations backK130247 Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · Recalled
- 1 generation backK162447 PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I.…Pentax of America, Inc. · 2017
- This deviceK182004 PENTAX Medical Endoscopic Ultrasound SystemPentax of America, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK200090 PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U…Pentax of America, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 0 of its ownK232518 EndoSound Vision System; EVSEndosound, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK203166 PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX…Pentax of America, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K200090PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI…Pentax of America, Inc. · 2020 · cites it directly2descendants
- K232518EndoSound Vision System; EVSEndosound, Inc. · 2023 · 2 generations on0descendants
- K203166PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound…Pentax of America, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| −7 | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | 2 |
| −6 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
| −5 | K021278 | EG-3630UR, Ultrasound Video Gastroscope | Pentax Precision Instrument Corp. | 2002 | — |
| −4 | K023401 | EG-3830UT, Video Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2003 | — |
| −3 | K090197 | EG-3870UTK | Pentax Medical Company | 2009 | 2 |
| −2 | K130247 | Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | 1 |
| −1 | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope… | Pentax of America, Inc. | 2017 | — |
| 0 (this device) | K182004 | PENTAX Medical Endoscopic Ultrasound System | Pentax of America, Inc. | 2018 | — |
| +1 | K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound… | Pentax of America, Inc. | 2020 | 2 |
| +2 | K232518 | EndoSound Vision System; EVS | Endosound, Inc. | 2023 | — |
| +2 | 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 | 2 | 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 |
|---|---|---|---|
| * | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex…Summary page 4…Name: Endoscopic Ultrasound / Ultrasound Gastroscope Name of the System: PENTAX Medical Endoscopic Ultrasound System EG-3270UK Upper G.I. Video Scope (Convex Array Type, K162447), EG-3670URK Video Gastroscope (Radial Array Type, K130206) and EG-3870UTK (Convex Array Type, K130247) with EPK-i5010 Video Proc… | 2017 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI… | 2020 | 2 |
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-0308-2027 | 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-0309-2027 | 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 37 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K200090 (Pentax of America, Inc., 2020) has gone furthest, with 2 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. 2018, 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 Endoscopic Ultrasound System is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to the organs, tissues, and subsystems: Esophagus, Stomach, Duodenum, Small Bowel, 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 as stated in the FDA summary.
https://510kreport.com/device/K182004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K182004: PENTAX Medical Endoscopic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K182004
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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