510(k) · Cleared
ClearedOlympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Optical, Co. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Nov 16, 1998 as substantially equivalent to K951994 (Olympus America, Inc., 1996) and 3 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1993. 1 of the 72 devices in its family, counting itself, has a Class I recall. 67 later devices descend from it.
- Decided
- Nov 16, 1998
- Review
- 112 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K926514 (1993). 4 ancestors in all, the oldest K882061 (1988). 67 later devices descend from it, 6 citing it directly. 1 of the 72 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 1 generation backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- This deviceK982610 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 · 44 of its ownK021204 Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002
- Descendant · 3 generations on · 43 of its ownK042140 Olympus BF Type UC160-OL8Olympus Corporation · 2004 · Recalled
- Descendant · 4 generations on · 28 of its ownK050503 Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · Recalled
- Descendant · 2 generations on · 16 of its ownK043275 Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation · 2004
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193517 ViziShot 2 FLEX7 generations on · 2020
Most influential descendants
Showing 5 of 67 · See all- K011886Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic…Olympus America, Inc. · 2001 · cites it directly60descendants
- K021204Olympus BF Type UM40Olympus Optical Co., Ltd. · 2002 · 2 generations on44descendants
- K042140Olympus BF Type UC160-OL8Olympus Corporation · 2004 · 3 generations on43descendants
- K050503Single Use Aspiration Needle NA-201SX-4022Olympus Medical Systems Corporation · 2005 · 4 generations on28descendants
- K043275Olympus EU-M60 Eus Exera Endoscopic Ultrasound CenterOlympus Medical Systems Corporation · 2004 · 2 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −1 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| 0 (this device) | 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 | K021204 | Olympus BF Type UM40 | Olympus Optical Co., Ltd. | 2002 | — |
| +3 | K042140 | Olympus BF Type UC160-OL8 | Olympus Corporation | 2004 | 1 |
| +4 | K050503 | Single Use Aspiration Needle NA-201SX-4022 | Olympus Medical Systems Corporation | 2005 | 5 |
| +2 | K043275 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound Center | Olympus Medical Systems Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 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 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 8 | 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 ITX device
- #1 K260114 Align® Cover and Pad Guidance Toolscore 13.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 1…r Class I, 21CFR 892.1570 & Classification Name: Diagnostic ultrasound transducer Class I1, 21CFR876.1500 Endoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R / UM-3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted By: Laura Storms-Tyler (Contact Pers… | 1996 |
| * | K944610 | Olympus Ultrasonic ProbesSummary page 1…ssification Name: Diagnostic ultrasound transducer Class I1, 21CFR876.1500 Endoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R / UM-3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted By: Laura Storms-Tyler (Contact Person) Olympus America Inc. Regula… | 1995 |
| * | K926514 | Endoscopic Ultrasound System Type 20Summary page 1…tic ultrasound transducer Class I1, 21CFR876.1500 Endoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R / UM-3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted By: Laura Storms-Tyler (Contact Person) Olympus America Inc. Regulatory Affairs Two Corpora… | 1993 |
| * | K882061 | Olympus GF-UM3/EU-M3Summary page 1…Class I1, 21CFR876.1500 Endoscope and accessories Predicate Devices: Olympus EU-M30 (K951994) Olympus UM-2R / UM-3R (K944610) Olympus EU-M20 (K926514) Olympus EU-M3 (K882061) Submitted By: Laura Storms-Tyler (Contact Person) Olympus America Inc. Regulatory Affairs Two Corporate Center Drive Melville,… | 1988 |
What descends from it? (67)
See all 676 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K011886 | Olympus EU-M60 Eus Exera Endoscopic Ultrasound CTR, Eus Exera Ultrasonic… | 2001 | 60 |
| K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope | 2007 | 15 |
| K092156 | Cad 12, Colonoscopy Assist Device | 2009 | 7 |
| K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | 2000 | 3 |
| K994106 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Bronchial Use | 2000 | 0 |
| K994069 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use | 2000 | 0 |
Has anything in its family been recalled? (1 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
What does this lineage say?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K011886 (Olympus America, Inc., 2001) has gone furthest, with 60 descendants of its own.
- 6 other devices also cite its predicate K951994.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITX
126in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITX
2in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · ITX
571in 2025
MAUDE reports naming product code ITX, 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 | 10 | 26 | 0 | 16 |
| 2008 | 12 | 73 | 4 | 39 |
| 2009 | 17 | 28 | 4 | 23 |
| 2010 | 10 | 42 | 4 | 30 |
| 2011 | 10 | 16 | 1 | 34 |
| 2012 | 7 | 25 | 1 | 29 |
| 2013 | 3 | 105 | 0 | 38 |
| 2014 | 4 | 41 | 1 | 43 |
| 2015 | 1 | — | 5 | 183 |
| 2016 | 4 | 151 | 0 | 269 |
| 2017 | 6 | 110 | 1 | 412 |
| 2018 | 2 | — | 15 | 130 |
| 2019 | 1 | — | 0 | 119 |
| 2020 | 3 | 120 | 3 | 116 |
| 2021 | 3 | 139 | 10 (10) | 146 |
| 2022 | 2 | — | 6 | 87 |
| 2023 | 6 | 213 | 1 | 138 |
| 2024 | 3 | 81 | 1 | 988 |
| 2025 | 4 | 126 | 2 | 571 |
| 2026 | 6 | 158 | 0 | — |
What is it indicated for?
New indications=Intraluminal ultrasound for urinary tract.
Previously cleared indications=Intraluminal ultrasound for gastrointestinal tract.
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/K982610 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982610: Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982610
Report an extraction error
Are you the manufacturer?
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