510(k) · Cleared
ClearedOlympus EU-M30 Endoscopic Ultrasound Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Apr 15, 1996 as substantially equivalent to K926514 (Olympus Corp., 1993) after a 353-day review. Its family tree reaches back 1 generation to 1993. 6 of the 150 devices in its family, counting itself, have a Class I recall. 148 later devices descend from it.
- Decided
- Apr 15, 1996
- Review
- 353 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926514 (1993). 148 later devices descend from it, 7 citing it directly. 6 of the 150 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- This deviceK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- Descendant · cites it directly · 142 of its ownK982323 Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary…Olympus America, Inc. · 1998
- Descendant · 2 generations on · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
- Descendant · cites it directly · 67 of its ownK982610 Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary…Olympus Optical, Co. · 1998
- Descendant · cites it directly · 60 of its ownK011886 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera…Olympus America, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 59 of its ownK010591 Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · Recalled
Showing 5 of 148 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 148 · See all- K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc. · 1998 · cites it directly142descendants
- K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · 2 generations on73descendants
- K982610Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Olympus Optical, Co. · 1998 · cites it directly67descendants
- K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc. · 2001 · cites it directly60descendants
- K010591Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound CenterOlympus Optical Co., Ltd. · 2001 · 2 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| 0 (this device) | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| +1 | K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for… | Olympus America, Inc. | 1998 | — |
| +2 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
| +1 | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary… | Olympus Optical, Co. | 1998 | — |
| +1 | K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | Olympus America, Inc. | 2001 | 1 |
| +2 | K010591 | Olympus EU-C60 Eus Exera Compact Endoscopic Ultrasound Center | Olympus Optical Co., Ltd. | 2001 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 10 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 11 | 0 |
| 2013 | 1 | 0 |
| 2014 | 10 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 5 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 1 |
| 2020 | 7 | 1 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 9 | 1 |
| 2024 | 5 | 2 |
| 2025 | 14 | 1 |
| 2026 | 6 | 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.
6 devices in this family have 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 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 |
|---|---|---|---|
| * | K926514 | Endoscopic Ultrasound System Type 20Summary page 1…/Usual Name: Endoscopic Ultrasound System Classification Name: System, Imaging, Pulsed Echo, Ultrasonic Endoscope and/or Accessories Predicate Devices: Olympus EU-M20 (K926514) Aloka SSD-550 Submitted By: Mr. Barry Sands (Contact Person) Olympus America Inc Medical Instrument Division 4 Nevada Drive… | 1993 |
| * | — | Aloka SSD-550 Ultrasound System Named without a submission number |
What descends from it? (148)
See all 1487 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use | 1998 | 142 |
| K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) | 1998 | 67 |
| K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | 2001 | 60 |
| K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | 2000 | 3 |
| K100899 | Olympus Endoscopic Flushing Pump, Model Opf-2 | 2010 | 1 |
| K231889 | Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic… | 2023 | 0 |
| K994106 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use | 2000 | 0 |
Has anything in its family been recalled? (6 Class I)
No FDA recall names this device.
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 · 7 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K190106Intra-Operative Positioning System; Simple Curve Catheter, Reverse Curve Catheter ; Angled Tip Guidewire…Centerline Biomedical, Inc. · 2019 · 12 generations on · ◆ in the 2019 descendants bar of FIG. 11 Class I recall
- K242133Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad); Intra-Operative Positioning System…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K241243Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters); Intra-Operative Positioning…Centerline Biomedical, Inc. · 2024 · 13 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
- K230309Intra-Operative Positioning System (IOPS®) (MC-1); IOPS Simple Curve Catheter (SCC-1) and IOPS Reverse Curve…Centerline Biomedical, Inc. · 2023 · 13 generations on · ◆ in the 2023 descendants bar of FIG. 11 Class I recall
- K243842Intra-Operative Positioning System (IOPS®)Centerline Biomedical, Inc. · 2025 · 13 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
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?
Olympus EU-M30 Endoscopic Ultrasound center is designed to be used in combination with the Olympus GF-UM20/JF-UM20/CF-UM20 ultrasonic endoscopes, Olympus UM-2R/UM-3R ultrasonic probes, and Olympus MH-908 esophageal ultrasonic probe for observation of real-time, ultrasonic images of upper GI tract, lower GI tract, and adjacent structures.
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/K951994 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951994: Olympus EU-M30 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/K951994
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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