510(k) · Cleared
ClearedOlympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus America, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 2, 2000 as substantially equivalent to K982610 (Olympus Optical, Co., 1998) and 1 other predicate after a 183-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jun 2, 2000
- Review
- 183 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K872027 (1987). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK872027 Olympus GF-UM2/EU-M2Olympus Corp. · 1987
- 2 generations backK961048 Olympus MH-246R Balloon SheathOlympus America, Inc. · 1996
- 1 generation backK982734 Olympus MH-246R Balloon Sheath, for Urinary Tract UseThe Olympus Optical Co. · 1998
- This deviceK994069 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K872027 | Olympus GF-UM2/EU-M2 | Olympus Corp. | 1987 | — |
| −2 | K961048 | Olympus MH-246R Balloon Sheath | Olympus America, Inc. | 1996 | — |
| −1 | K982734 | Olympus MH-246R Balloon Sheath, for Urinary Tract Use | The Olympus Optical Co. | 1998 | — |
| 0 (this device) | K994069 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | Olympus America, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 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 ITX? 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? (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 |
|---|---|---|---|
| * | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary Tract)Summary page 2…sonic Probe Classification Name: 21 CFR892.1570 Diagnostic Ultrasonic transducer 994069 Predicate Device: MODEL | NAME 510(k)# UM-2R Ultrasonic Probe K982610 UM-3R Ultrasonic Probe K982610 EU-M30 | Endoscopic Ultrasound Center | K982610 MH-240 | Probe Driving Unit K982610 MH-246 | B… | 1998 |
| * | K982734 | Olympus MH-246R Balloon Sheath, for Urinary Tract UseSummary page 2…R Ultrasonic Probe K982610 UM-3R Ultrasonic Probe K982610 EU-M30 | Endoscopic Ultrasound Center | K982610 MH-240 | Probe Driving Unit K982610 MH-246 | Balloon Sheath K982734 (for UM-2R/3R) D. Description of the Device(s) The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Oly… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 13 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 5 other devices also cite its predicate K982610.
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?
The Olympus UM-S30-25R Ultrasonic Probe has been designed to be used with an Olympus Endoscopic Ultrasound center, Probe Driving Unit and an endoscope for intraluminal ultrasonic imaging of the urinary 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/K994069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994069: Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for Urinary Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994069
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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