510(k) · Cleared
Recalled · Class II · 2020Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Aug 27, 2001 as substantially equivalent to K951994 (Olympus America, Inc., 1996) and 5 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1986. 1 of the 72 devices in its family, counting itself, has a Class I recall. 60 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2001
- Review
- 73 days
- Class
- Class II
- Product code
- ODG
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 3 generations to K853585 (1986). 11 ancestors in all. 60 later devices descend from it, 3 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
- This deviceK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001
- Descendant · cites it directly · 44 of its ownK021204 Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002
- Descendant · 2 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 3 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · cites it directly · 16 of its ownK043275 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation · 2004
- Descendant · cites it directly · 15 of its ownK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX6 generations on · 2020
Most influential descendants
Showing 5 of 60 · See all- K021204Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002 · cites it directly44descendants
- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 2 generations on43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 3 generations on28descendants
- K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation · 2004 · cites it directly16descendants
- K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation · 2007 · cites it directly15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
| 0 (this device) | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | Olympus America, Inc. | 2001 | — |
| +1 | K021204 | Olympus BF Type UM40 | Olympus Optical Co., Ltd. | 2002 | — |
| +2 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +3 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +1 | K043275 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center | Olympus Medical Systems Corporation | 2004 | — |
| +1 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 1 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 3 | 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.
1 device in this family has a Class I recall. 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? (6)
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 |
|---|---|---|---|
| * | K951994 | Olympus EU-M30 Endoscopic Ultrasound CenterSummary page 9…is device is substantially equivalent to a legally marketed, predicate medical device. 1. Uitrasound System Device Name #K Olympus EU-M30 Endoscopic Ultrasound Center K951994 2. Ultrasonic Gastrovideoscope and Probes Device Name : #K Olympus GF TYPE UM130 Ultrasound Gastrovideoscope K971660 Olympus UM… | 1996 |
| * | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Summary page 9…me #K Olympus EU-M30 Endoscopic Ultrasound Center K951994 2. Ultrasonic Gastrovideoscope and Probes Device Name : #K Olympus GF TYPE UM130 Ultrasound Gastrovideoscope K971660 Olympus UM-2R/3R Ultrasonic Probes and associated K944610 ancillary equipment for Gl Olympus UM-2R/ 3R Ultrasonic Probes and asso… | 1997 |
| * | K944610 | Olympus Ultrasonic ProbesSummary page 9…2. Ultrasonic Gastrovideoscope and Probes Device Name : #K Olympus GF TYPE UM130 Ultrasound Gastrovideoscope K971660 Olympus UM-2R/3R Ultrasonic Probes and associated K944610 ancillary equipment for Gl Olympus UM-2R/ 3R Ultrasonic Probes and associated K982323 ancillary equipment (for bronchial use) Oly… | 1995 |
| * | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseSummary page 9…trasound Gastrovideoscope K971660 Olympus UM-2R/3R Ultrasonic Probes and associated K944610 ancillary equipment for Gl Olympus UM-2R/ 3R Ultrasonic Probes and associated K982323 ancillary equipment (for bronchial use) Olympus UM-2R/3R Ultrasonic Probes and associated K982610 ancillary equipment (for urina… | 1998 |
| * | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Summary page 9…ary equipment for Gl Olympus UM-2R/ 3R Ultrasonic Probes and associated K982323 ancillary equipment (for bronchial use) Olympus UM-2R/3R Ultrasonic Probes and associated K982610 ancillary equipment (for urinary tract) Olympus UM-2R/3R Ultrasonic Probe and associated ancillary K001203 equipment (Ob/Gyn) =… | 1998 |
| * | K001203 | Olympus UM 2R/3R Ultrasonic Probe and Associated Ancillary Equipment for Female…Summary page 9…nchial use) Olympus UM-2R/3R Ultrasonic Probes and associated K982610 ancillary equipment (for urinary tract) Olympus UM-2R/3R Ultrasonic Probe and associated ancillary K001203 equipment (Ob/Gyn) D. Device Description 1. Summary The combination of OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULT… | 2000 |
What descends from it? (60)
See all 603 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2020 | Class II | Z-0504-2021 | Device Design | A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 6 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K021204 (Olympus Optical Co., Ltd., 2002) has gone furthest, with 44 descendants of its own.
- 6 other devices also cite its predicate K951994.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K011886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011886: Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic Gastrovideoscope Olympus GF Type UM 160,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011886
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026