510(k) · Cleared
ClearedEVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Jul 31, 2026 as substantially equivalent to K251859 (Olympus Medical Systems Corporation, 2025) after a 112-day review. Its family tree reaches back 5 generations to 1986.
- Decided
- Jul 31, 2026
- Review
- 112 days
- Class
- Class II
- Product code
- ODG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K853585 (1986). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 4 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 3 generations backK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
- 2 generations backK051541 GF-UE160-AL5 Ultrasound EndoscopeOlympus America, Inc. · 2005 · Recalled
- 1 generation backK251859 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation · 2025
- This deviceK261183 EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Olympus Medical Systems Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −4 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −3 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
| −2 | K051541 | GF-UE160-AL5 Ultrasound Endoscope | Olympus America, Inc. | 2005 | 2 |
| −1 | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | 2025 | — |
| 0 (this device) | K261183 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) | Olympus Medical Systems Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2001 | 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 |
|---|---|---|---|
| * | K251859 | EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190)Summary page 5…510(k) No. EVIS EUS ULTRASOUND OLYMPUS MEDICAL GASTROINTENSTINAL VIDEOSCOPE SYSTEMS CORP. K251859 OLYMPUS GF-UE190 510(k) Summary… | 2025 |
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 40 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- 6 of the 8 ancestors have a recall of any class.
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. 2026, 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 EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 has
been designed to be used with diagnostic ultrasound system, video system center, light source,
documentation equipment, monitor, endoscopic therapy accessories and other ancillary equipment.
The EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPE OLYMPUS GF-UE190 is
designed for endoscopic real-time ultrasound imaging, and other endoscopic procedures within the
upper gastrointestinal tract and surrounding organs.
Operator qualifications
Appropriately trained healthcare professionals.
Device use settings
Healthcare facility
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/K261183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261183: EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261183
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026