510(k) · Cleared
Recalled · Class II · 2020Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical Co., Ltd. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Mar 15, 2001 as substantially equivalent to K994096 (Sonosite,Inc., 1999) and 7 other predicates after a 15-day review. Its family tree reaches back 5 generations to 1989. 1 of the 98 devices in its family, counting itself, has a Class I recall. 59 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 15, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- ODG
- Recalls
- 2
- Predicates
- 8
Its longest line of descent runs back 5 generations to K894632 (1989). 38 ancestors in all, the oldest K812810 (1981). 59 later devices descend from it, 3 citing it directly. 1 of the 98 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK894632 Model SSH-140A Ultrasound Imaging SystemToshiba America Medical Systems, In.C · 1989
- 4 generations backK941593 Diagnostic Ultrasonic TransducerToshiba America Medical Systems, In.C · 1996
- 3 generations backK970047 Phased Array Transducer - - PSK-20CTToshiba America Medical Systems, In.C · 1997
- 2 generations backK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- 1 generation backK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- This deviceK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001
- Descendant · cites it directly · 44 of its ownK031347 Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003
- Descendant · cites it directly · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 2 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · cites it directly · 15 of its ownK063683 Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic…Olympus Medical Systems Corporation · 2007
- Descendant · 2 generations on · 11 of its ownK070983 Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with…Olympus Medical Systems Corporation · 2007 · Recalled
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX5 generations on · 2020
Most influential descendants
Showing 5 of 59 · See all- K031347Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8Olympus Optical Co., Ltd. · 2003 · cites it directly44descendants
- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · cites it directly43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 2 generations on28descendants
- K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation · 2007 · cites it directly15descendants
- K070983Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10…Olympus Medical Systems Corporation · 2007 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894632 | Model SSH-140A Ultrasound Imaging System | Toshiba America Medical Systems, In.C | 1989 | — |
| −4 | K941593 | Diagnostic Ultrasonic Transducer | Toshiba America Medical Systems, In.C | 1996 | — |
| −3 | K970047 | Phased Array Transducer - - PSK-20CT | Toshiba America Medical Systems, In.C | 1997 | — |
| −2 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| −1 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| 0 (this device) | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | — |
| +1 | K031347 | Ultrasonic Gastrovideoscope, Type UC160P-AT8 and UCT160-AT8 | Olympus Optical Co., Ltd. | 2003 | — |
| +1 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +2 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +1 | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic… | Olympus Medical Systems Corporation | 2007 | — |
| +2 | K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka… | Olympus Medical Systems Corporation | 2007 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 8 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 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? (9)
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 |
|---|---|---|---|
| * | K994096 | Sonoheart Hand-Carried Echocardiography SystemSummary page 11…2R/UM-3R Ultrasonic Probes Olympus BF Type 240 Bronchovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a… | 1999 |
| * | K961459 | Level 10 HdiSummary page 11…Ultrasonic Probes Olympus BF Type 240 Bronchovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general p… | 1997 |
| * | K963023 | Ultrasound Gastroscope GF Type UM30PSummary page 11…robes Olympus BF Type 240 Bronchovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general purpose, comp… | 1997 |
| * | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Summary page 11…ympus BF Type 240 Bronchovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general purpose, compact, sof… | 1997 |
| * | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseSummary page 11…Type 240 Bronchovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general purpose, compact, software-co… | 1998 |
| * | K963033 | BF 240/P240/IT240 Bronchovideoscope & AccessoriesSummary page 11…0 Bronchovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general purpose, compact, software-controlled… | 1996 |
| * | K954451 | Evis 140 SystemSummary page 11…ovideoscopes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general purpose, compact, software-controlled, diagno… | 1996 |
| * | K961974 | FG-36UX, Ultrasound Upper GI FiberscopeSummary page 11…opes Olympus GIF-1T140 Video Gastroscope Pentax FG-36UX, Ultrasound Upper Gl Fiberscope System #K K0033399 K994096 K961459 #K K963023 K971660 K982323 K963033 K954451 K961974 D. Device Description 1. Summary The EU-C60 is a general purpose, compact, software-controlled, diagnostic ul… | 1997 |
| * | — | SonoSite™ Hand-Carried Ultrasound System Named without a submission number |
What descends from it? (59)
See all 593 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-0505-2021 | 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. |
| Oct 16, 2020 | Class II | Z-0506-2021 | 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 · 5 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K031347 (Olympus Optical Co., Ltd., 2003) has gone furthest, with 44 descendants of its own.
- 1 other device also cites its predicate K994096.
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:
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/K010591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010591: Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010591
Report an extraction error
Are you the manufacturer?
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