510(k) · Cleared
ClearedIntra-Operative Ultrasound Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hitachi Aloka Medical, Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jun 11, 2014 as substantially equivalent to K122537 (Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical, 2013) after a 69-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.
- Decided
- Jun 11, 2014
- Review
- 69 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K954022 (1996). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- 5 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- 4 generations backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
- 3 generations backK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
- 2 generations backK072285 Aloka SSD-Alpha 7 Ultrasound SystemAloka Co., Ltd. · 2007
- 1 generation backK122537 Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model…Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical · 2013
- This deviceK140854 Intra-Operative Ultrasound TransducerHitachi Aloka Medical, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK142618 Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic…Hitachi Aloka Medical America, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K142618Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System…Hitachi Aloka Medical America, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| −5 | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| −4 | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | Aloka Co. Ltd USA | 2003 | — |
| −3 | K043196 | Aloka SSD-Alpha 10 Ultrasound System | Aloka Co., Ltd. | 2004 | — |
| −2 | K072285 | Aloka SSD-Alpha 7 Ultrasound System | Aloka Co., Ltd. | 2007 | — |
| −1 | K122537 | Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha… | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | 2013 | — |
| 0 (this device) | K140854 | Intra-Operative Ultrasound Transducer | Hitachi Aloka Medical, Ltd. | 2014 | — |
| +1 | K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound… | Hitachi Aloka Medical America, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K122537 | Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0Summary page 1…Product Code: 90-ITX 892.1570 Diagnostic Ultrasonic Transducer 3. Legally Marketed Predicate Device(s): UST-533 Intraoperative Ultrasound Transducer [K122537i UJST-534 Intraoperative Ultrasound i'ransducer [K1 22537]1 UST-536 Intraoperative Ultrasound Transducer [K1225… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142618 | Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound System… | 2014 | 0 |
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 18 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K142618 (Hitachi Aloka Medical America, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ITX devicesITX Transducer, Ultrasonic, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Hitachi Aloka Medical, Ltd. UST-5310/ UST-5311 transducers for use with the PROSOUND ALPHA6 Diagnostic Ultrasound scanner are intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation during Intra-operative and Intra-operative (Neurosurgery) procedures.
The device is not indicated for Ophthalmic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140854 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140854: Intra-Operative Ultrasound Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140854
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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