510(k) · Cleared
Recalled · Class II · 2020Endoscopic Ultrasound System Type 20
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · ODG Endoscopic Ultrasound System, Gastroenterology-Urology
Cleared on Aug 16, 1993 after a 229-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 of the 196 devices in its family, counting itself, have a Class I recall. 195 later devices descend from it. It has been recalled once.
- Decided
- Aug 16, 1993
- Review
- 229 days
- Class
- Class II
- Product code
- ODG
- Recalls
- 1
- Predicates
- 0
195 later devices descend from it, 6 citing it directly. 6 of the 196 devices in this family, counting this one, have a Class I recall.
- This deviceK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993
- Descendant · cites it directly · 148 of its ownK951994 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 · cites it directly · 88 of its ownK963023 Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997
- Descendant · cites it directly · 75 of its ownK971660 Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated…Olympus America, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 73 of its ownK042438 Superdimension/BronchusSuperdimension, Ltd. · 2004 · Recalled
Showing 5 of 195 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 195 · See all- K951994Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996 · cites it directly148descendants
- K982323Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial UseOlympus America, Inc. · 1998 · cites it directly142descendants
- K963023Ultrasound Gastroscope GF Type UM30POlympus America, Inc. · 1997 · cites it directly88descendants
- K971660Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary…Olympus America, Inc. · 1997 · cites it directly75descendants
- K042438Superdimension/BronchusSuperdimension, Ltd. · 2004 · 2 generations on73descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | — |
| +1 | 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 | — |
| +1 | K963023 | Ultrasound Gastroscope GF Type UM30P | Olympus America, Inc. | 1997 | — |
| +1 | K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and… | Olympus America, Inc. | 1997 | 2 |
| +2 | K042438 | Superdimension/Bronchus | Superdimension, Ltd. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 6 | 0 |
| 2008 | 6 | 0 |
| 2009 | 11 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 12 | 0 |
| 2013 | 1 | 0 |
| 2014 | 10 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 11 | 1 |
| 2020 | 10 | 1 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 12 | 1 |
| 2024 | 6 | 2 |
| 2025 | 18 | 1 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (195)
See all 1956 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | 1996 | 148 |
| K982323 | Olympus UM 2R/3R Ultrasonic Probes and Associated Ancillary Equipment, for Bronchial Use | 1998 | 142 |
| K963023 | Ultrasound Gastroscope GF Type UM30P | 1997 | 88 |
| K971660 | Olympus GF-UM130 Ultrasound Gastrovideoscope, Its Associated Accessories and Ancillary… | 1997 | 75 |
| K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract) | 1998 | 67 |
| K961048 | Olympus MH-246R Balloon Sheath | 1996 | 5 |
Has anything in its family been recalled? (6 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2020 | Class II | Z-0501-2021 | 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 · 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?
- Of its descendants, K951994 (Olympus America, Inc., 1996) has gone furthest, with 148 descendants of its own.
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 | — |
https://510kreport.com/device/K926514 · printed Nov 6, 2026
Cite this page
510(k) Report. “K926514: Endoscopic Ultrasound System Type 20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K926514
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026