510(k) · Cleared
ClearedUltrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 11, 2025 as substantially equivalent to K231666 (FUJIFILM Healthcare Americas Corporation, 2023) after a 120-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Jul 11, 2025
- Review
- 120 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K926514 (1993). 8 ancestors in all, the oldest K882061 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK926514 Endoscopic Ultrasound System Type 20Olympus Corp. · 1993 · Recalled
- 4 generations backK951994 Olympus EU-M30 Endoscopic Ultrasound CenterOlympus America, Inc. · 1996
- 3 generations backK982610 Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary…Olympus Optical, Co. · 1998
- 2 generations backK994103 Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary…Olympus America, Inc. · 2000
- 1 generation backK231666 Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe…FUJIFILM Healthcare Americas Corporation · 2023
- This deviceK250762 Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe…Olympus Medical Systems Corporation · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K926514 | Endoscopic Ultrasound System Type 20 | Olympus Corp. | 1993 | 1 |
| −4 | K951994 | Olympus EU-M30 Endoscopic Ultrasound Center | Olympus America, Inc. | 1996 | — |
| −3 | K982610 | Olympus UM-2R/3R Ultrasonic Probes and Associated Ancillary Equipment (Urinary… | Olympus Optical, Co. | 1998 | — |
| −2 | K994103 | Olympus UM-S30-25R Ultrasonic Probe and Associated Ancillary Equipment for… | Olympus America, Inc. | 2000 | — |
| −1 | K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | FUJIFILM Healthcare Americas Corporation | 2023 | — |
| 0 (this device) | K250762 | Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R… | Olympus Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1995 | 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? (1)
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 |
|---|---|---|---|
| * | K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)Summary page 6…UM-S20-17S and UM-S20-20R Device name 510(k) Submitter 510(k) No. FUJIFILM Endoscopic Ultrasonic Fujifilm Healthcare Americas K231666 Probe (P2612S-L); Endoscopic Corporation Ultrasonic Probe (P2620S-L) The Predicate device has not been subject to a des… | 2023 |
| † | K063683 | Olympus Xeu-M60A Endoscopic Ultrasound Center; XGF-UM180 Ultrasonic Gastrovideoscope | 2007 |
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 32 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K231666.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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 ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree. Modes of operation: The Mode of Operation is B mode. Operator qualifications: Appropriately trained healthcare professionals. Device use settings: Healthcare facility The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an…
Read the full statement (108 words)
The ULTRASONIC PROBE UM-S20-17S has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.
Modes of operation:
The Mode of Operation is B mode.
Operator qualifications:
Appropriately trained healthcare professionals.
Device use settings:
Healthcare facility
The ULTRASONIC PROBE UM-S20-20R has been designed to be used with an endoscopic ultrasound center, a probe driving unit, and an endoscope for intraluminal ultrasonic imaging of the upper airways and tracheobronchial tree.
Modes of operation:
The Mode of Operation is B mode.
Operator qualifications:
Appropriately trained healthcare professionals.
Device use settings:
Healthcare facility
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/K250762 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250762: Ultrasonic Probe UM-S20-17S (UM-S20-17S); Ultrasonic Probe UM-S20-20R (UM-S20-20R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250762
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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