510(k) · Cleared
ClearedOlympus EU-M60 Eus Exera Endoscopic Ultrasound Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Dec 9, 2004 as substantially equivalent to K011886 (Olympus America, Inc., 2001) and 1 other predicate after a 13-day review. Its family tree reaches back 4 generations to 1986. 16 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K853585 (1986). 13 ancestors in all. 16 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
- 1 generation backK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
- This deviceK043275 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
- Descendant · 2 generations on · 7 of its ownK092156 Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK121564 Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012
- Descendant · 3 generations on · 6 of its ownK100624 Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012
- Descendant · 4 generations on · 5 of its ownK121582 Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K063683Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic GastrovideoscopeOlympus Medical Systems Corporation · 2007 · cites it directly15descendants
- K092156Cad 12, Colonoscopy Assist DeviceSoftscope Medical Technologies, Inc. · 2009 · 2 generations on7descendants
- K121564Endoscopic Ultrasound Center EU-Y0006Olympus Medical Systems Corp. · 2012 · 2 generations on6descendants
- K100624Invendo C20 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 3 generations on6descendants
- K121582Invendo C25 Colonoscopy SystemInvendo Medical Gbmh · 2012 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
| −1 | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | Olympus America, Inc. | 2001 | 1 |
| 0 (this device) | 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 | — |
| +2 | K092156 | Cad 12, Colonoscopy Assist Device | Softscope Medical Technologies, Inc. | 2009 | — |
| +2 | K121564 | Endoscopic Ultrasound Center EU-Y0006 | Olympus Medical Systems Corp. | 2012 | — |
| +3 | K100624 | Invendo C20 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
| +4 | K121582 | Invendo C25 Colonoscopy System | Invendo Medical Gbmh | 2012 | — |
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 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Summary page 2…Device Name #K OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER K01 1886 ATL HDI 5000 Ultrasound System K961459 D. Device Description 1.… | 2001 |
| * | K961459 | Level 10 HdiSummary page 2…EUS EXERA ENDOSCOPIC ULTRASOUND CENTER K01 1886 ATL HDI 5000 Ultrasound System K961459 D. Device Description 1. Summary The OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER makes a endoscopi… | 1997 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope | 2007 | 15 |
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 18 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K063683 (Olympus Medical Systems Corporation, 2007) has gone furthest, with 15 descendants of its own.
- 2 other devices also cite its predicate K011886.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
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 as stated in the FDA summary.
https://510kreport.com/device/K043275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043275: Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043275
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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