510(k) · Cleared
ClearedUltrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R)
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 Sep 18, 2025 as substantially equivalent to K231666 (FUJIFILM Healthcare Americas Corporation, 2023) after a 178-day review. Its family tree reaches back 5 generations to 1993.
- Decided
- Sep 18, 2025
- Review
- 178 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 deviceK250883 Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R…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) | K250883 | Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R) | 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…C PROBE UM-3R and UM-G20-29R Device Name 510(k) Submitter 510(k) No. Endoscopic Ultrasonic Probe (P2612S-L); FUJIFILM Corporation K231666 Endoscopic Ultrasonic Probe (P2620S-L) The Predicate device has not been subject to a design-related recall. A Reference devic… | 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-3R has been designed to be used with an Olympus endoscopic ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and surrounding organs. This product is intended for use in adults. [Modes of operation] The Mode of Operation is B mode. [Operator qualifications]…
Read the full statement (160 words)
The ULTRASONIC PROBE UM-3R has been designed to be used with an Olympus endoscopic ultrasound
center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal ultrasonic imaging
of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic ducts and
surrounding organs. This product is intended for use in adults.
[Modes of operation]
The Mode of Operation is B mode.
[Operator qualifications]
Appropriately trained healthcare professionals.
[Device use settings]
Professional healthcare facility (no domestic or special environments)
The ULTRASONIC PROBE UM-G20-29R has been designed to be used with an Olympus endoscopic
ultrasound center, a probe driving unit, other ancillary equipment and an endoscope for intraluminal
ultrasonic imaging of the gastrointestinal tract, biliary tract (common bile, cystic, intrahepatic), pancreatic
ducts and surrounding organs. This product is intended for use in adults.
[Modes of operation]
The Mode of Operation is B mode.
[Operator qualifications]
Appropriately trained healthcare professionals.
[Device use settings]
Professional healthcare facility (no domestic or special environments)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250883: Ultrasonic Probe UM-3R (UM-3R); Ultrasonic Probe UM-G20-29R (UM-G20-29R).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250883
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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