510(k) · Cleared
Recalled · Class II · 2017EG-3670URK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pentax Medical Company · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on May 3, 2006 as substantially equivalent to K041395 (Pentax Precision Instrument Corp., 2004) and 1 other predicate after a 16-day review. Its family tree reaches back 4 generations to 1981. 3 later devices descend from it. It has been recalled once.
- Decided
- May 3, 2006
- Review
- 16 days
- Class
- Class II
- Product code
- ODG
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K812810 (1981). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK812810 Pentax Flexible DriodenofiberscopePentax Precision Instrument Corp. · 1981
- 3 generations backK961974 FG-36UX, Ultrasound Upper GI FiberscopePentax Precision Instrument Corp. · 1997 · Recalled
- 2 generations backK010740 FG-36UX, Fiber Ultrasound GastroscopePentax Precision Instrument Corp. · 2001
- 1 generation backK041395 EG-3630URPentax Precision Instrument Corp. · 2004
- This deviceK061068 EG-3670URKPentax Medical Company · 2006
- Descendant · cites it directly · 2 of its ownK090196 EG-3670URKPentax Medical Company · 2009 · Recalled
- Descendant · 2 generations on · 1 of its ownK130206 Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013
- Descendant · 3 generations on · 0 of its ownK231813 Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024
Most influential descendants
Showing 3 of 3 · See all- K090196EG-3670URKPentax Medical Company · 2009 · cites it directly2descendants
- K130206Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision PreirusPentax of America, Inc. · 2013 · 2 generations on1descendant
- K231813Ultrasonic GastrovideoscopeSonoscape Medical Corp. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K812810 | Pentax Flexible Driodenofiberscope | Pentax Precision Instrument Corp. | 1981 | — |
| −3 | K961974 | FG-36UX, Ultrasound Upper GI Fiberscope | Pentax Precision Instrument Corp. | 1997 | 2 |
| −2 | K010740 | FG-36UX, Fiber Ultrasound Gastroscope | Pentax Precision Instrument Corp. | 2001 | — |
| −1 | K041395 | EG-3630UR | Pentax Precision Instrument Corp. | 2004 | — |
| 0 (this device) | K061068 | EG-3670URK | Pentax Medical Company | 2006 | — |
| +1 | K090196 | EG-3670URK | Pentax Medical Company | 2009 | 1 |
| +2 | K130206 | Pentax EG-3670URK Ultrasound Video Gastroscope + HI Vision Preirus | Pentax of America, Inc. | 2013 | — |
| +3 | K231813 | Ultrasonic Gastrovideoscope | Sonoscape Medical Corp. | 2024 | — |
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 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K041395 | EG-3630URSummary page 1…Manufacturer EG-3630UR, Video Ultrasound Gastroscope Pentax Corporation K041395 IEUB-5500, Ultrasound Diagnostic Scanner Hitachi America K032503 Device Descripti… | 2004 |
| * | K032503 | Eub-5500 Diagnostic Ultrasound ScannerSummary page 1…Pentax Corporation K041395 IEUB-5500, Ultrasound Diagnostic Scanner Hitachi America K032503 Device Description: The EG-3670URK, Ultrasound Video Gastroscope, must be used with a Pentax Video Processor (software cont… | 2003 |
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 |
|---|---|---|---|
| K090196 | EG-3670URK | 2009 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 23, 2017 | Class II | Z-3067-2017 | Error in labeling | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K090196 (Pentax Medical Company, 2009) 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.
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 EG-3670OURK, Ultrasound Video Gastroscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Upper Gastrointestinal Track. The Upper Gastrointestinal Track includes but is 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.
Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061068 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061068: EG-3670URK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061068
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