510(k) · Cleared
ClearedUst-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aloka Co., Ltd. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Feb 12, 1993 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.
- Decided
- Feb 12, 1993
- Review
- 105 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK925486 Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans.Aloka Co., Ltd. · 1993
- Descendant · cites it directly · 1 of its ownK972192 Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK981834 Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK953759 Diagnostic Ultrasound TransducerBiosound, Inc. · 1996
Most influential descendants
Showing 3 of 3 · See all- K972192Perception Inc. GPS-Xyz Diagnostic Ultrasound SystemPerception, Inc. · 1997 · cites it directly1descendant
- K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998 · 2 generations on0descendants
- K953759Diagnostic Ultrasound TransducerBiosound, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925486 | Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans. | Aloka Co., Ltd. | 1993 | — |
| +1 | K972192 | Perception Inc. GPS-Xyz Diagnostic Ultrasound System | Perception, Inc. | 1997 | — |
| +2 | K981834 | Perception Inc, GPS-6TBMD Diagnostic Ultrasound System | Perception, Inc. | 1998 | — |
| +1 | K953759 | Diagnostic Ultrasound Transducer | Biosound, Inc. | 1996 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K972192 (Perception, Inc., 1997) has gone furthest, with 1 descendant 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.
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 | — |
https://510kreport.com/device/K925486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925486: Ust-5522-7.5 & Ust-5522L-7.5 Intraoperative Trans..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925486
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026