510(k) · Cleared
Recalled · 2009V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Aug 17, 2005 as substantially equivalent to K051139 (Siemens Medical Solutions USA, Inc., 2005) and 3 other predicates after a 22-day review. Its family tree reaches back 6 generations to 1995. 2 of the 844 devices in its family, counting itself, have a Class I recall. 806 later devices descend from it. It has been recalled once.
- Decided
- Aug 17, 2005
- Review
- 22 days
- Class
- Class II
- Product code
- ITX
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 6 generations to K935595 (1995). 37 ancestors in all, the oldest K891689 (1989). 806 later devices descend from it, 3 citing it directly. 2 of the 844 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK935595 Acuson Model 3001Acuson Corp. · 1995
- 5 generations backK973767 Harmonic Imaging with ContrastAcuson Corp. · 1997
- 4 generations backK022567 Sequoia Signature II Diagnostic Ultrasound SystemAcuson Corp. · 2002
- 3 generations backK032114 Sequoia 8.0 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2003
- 2 generations backK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
- 1 generation backK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
- This deviceK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005
- Descendant · cites it directly · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006
- Descendant · 2 generations on · 801 of its ownK063803 Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · Recalled
- Descendant · 3 generations on · 800 of its ownK072786 Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 4 generations on · 588 of its ownK093563 IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · Recalled
- Descendant · 4 generations on · 582 of its ownK083095 Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008
Showing 5 of 806 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 806 · See all- K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · cites it directly802descendants
- K063803Acuson Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc., Ultrasound DI · 2007 · 2 generations on801descendants
- K072786Acuson S2000 Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on800descendants
- K093563IU22 Ultrasound System and TransducersPhilips Ultrasound, Inc. · 2010 · 4 generations on588descendants
- K083095Sonixtouch Ultrasound SystemUltrasonix Medical Corporation · 2008 · 4 generations on582descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K935595 | Acuson Model 3001 | Acuson Corp. | 1995 | — |
| −5 | K973767 | Harmonic Imaging with Contrast | Acuson Corp. | 1997 | — |
| −4 | K022567 | Sequoia Signature II Diagnostic Ultrasound System | Acuson Corp. | 2002 | — |
| −3 | K032114 | Sequoia 8.0 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2003 | — |
| −2 | K041319 | Sequoia Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2004 | — |
| −1 | K042770 | Modification to Acuson CV70 Cardiovascular System | Siemens Medical Solutions USA, Inc. | 2004 | 1 |
| 0 (this device) | K052021 | V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer | Siemens Medical Solutions USA, Inc. | 2005 | — |
| +1 | K063138 | Modification to Acuson Antares Ultrasound System | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +2 | K063803 | Acuson Antares Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2007 | 9 |
| +3 | K072786 | Acuson S2000 Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +4 | K093563 | IU22 Ultrasound System and Transducers | Philips Ultrasound, Inc. | 2010 | 2 |
| +4 | K083095 | Sonixtouch Ultrasound System | Ultrasonix Medical Corporation | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1995 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 18 | 0 |
| 2012 | 28 | 0 |
| 2013 | 32 | 0 |
| 2014 | 45 | 0 |
| 2015 | 49 | 0 |
| 2016 | 58 | 0 |
| 2017 | 70 | 0 |
| 2018 | 61 | 0 |
| 2019 | 46 | 0 |
| 2020 | 63 | 0 |
| 2021 | 48 | 0 |
| 2022 | 52 | 0 |
| 2023 | 50 | 0 |
| 2024 | 54 | 0 |
| 2025 | 65 | 2 |
| 2026 | 46 | 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.
2 devices in this family have a Class I recall. 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? (4)
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 |
|---|---|---|---|
| * | K051139 | Acuson Sequoia Diagnostic Ultrasound SystemSummary page 1…90-ITX Predicate Devices: V5M TEE transducer has already been cleared on the following ACUSON ultrasound platforms: * ACUSON SequoiaiM ultrasound system (#K051139) * ACUSON CypressrM ultrasound system (#K042055) * ACUSON CV70TM cardiovascular systems (#K042770) Se imon… | 2005 |
| * | K042055 | Cypress Ultrasound SystemSummary page 1…er has already been cleared on the following ACUSON ultrasound platforms: * ACUSON SequoiaiM ultrasound system (#K051139) * ACUSON CypressrM ultrasound system (#K042055) * ACUSON CV70TM cardiovascular systems (#K042770) Se imon II 510(k) S u nary of S… | 2004 |
| * | K042770 | Modification to Acuson CV70 Cardiovascular SystemSummary page 1…trasound platforms: * ACUSON SequoiaiM ultrasound system (#K051139) * ACUSON CypressrM ultrasound system (#K042055) * ACUSON CV70TM cardiovascular systems (#K042770) Se imon II 510(k) S u nary of Safety and Effectiveness… | 2004 |
| * | K040060 | Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSummary page 2…51( (k) Devicc M/dl~ficaliom MPT7-4 TEE transducer has already been cleared on the following SONOLINE ultrasound platform: * SONOLINE G60SlM ultrasound system (#K040060) Device Description: The V5M/MPT7-4 transducers consist of a gastroscope control housing where nosepiece articulation and… | 2004 |
What descends from it? (806)
See all 8063 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2009 | Not classified | Z-0896-2011 | Software design | Software safety guard measures on the device malfunctioned to prevent the temperature from going over its limits when the device is used. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- 6 of the 37 ancestors have a recall of any class.
- Of its descendants, K063138 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 802 descendants of its own.
- 4 other devices also cite its predicate K051139.
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?
Ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound imaging or fluid flow analysis of the human body as follows:
Ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052021 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052021: V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052021
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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