510(k) · Cleared
ClearedPVK-720ST Endocavitary Transducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba America Medical Systems, In.C · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Mar 10, 1997 as substantially equivalent to K933743 (Toshiba America Medical Systems, In.C, 1994) and 2 other predicates after a 96-day review. Its family tree reaches back 1 generation to 1989. 3 of the 208 devices in its family, counting itself, have a Class I recall. 204 later devices descend from it.
- Decided
- Mar 10, 1997
- Review
- 96 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K891453 (1989). 3 ancestors in all. 204 later devices descend from it, 1 citing it directly. 3 of the 208 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK891453 Diagnostic Ultrasound Transducer: Pve-582VToshiba Medical Systems · 1989
- This deviceK964865 PVK-720ST Endocavitary TransducerToshiba America Medical Systems, In.C · 1997
- Descendant · cites it directly · 203 of its ownK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- Descendant · 2 generations on · 196 of its ownK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- Descendant · 3 generations on · 135 of its ownK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 4 generations on · 130 of its ownK092756 GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009
- Descendant · 4 generations on · 107 of its ownK090505 Speq Ultrasound SystemSignostics Pty, Ltd. · 2009
Showing 5 of 204 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 204 · See all- K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999 · cites it directly203descendants
- K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999 · 2 generations on196descendants
- K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on135descendants
- K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009 · 4 generations on130descendants
- K090505Speq Ultrasound SystemSignostics Pty, Ltd. · 2009 · 4 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891453 | Diagnostic Ultrasound Transducer: Pve-582V | Toshiba Medical Systems | 1989 | — |
| 0 (this device) | K964865 | PVK-720ST Endocavitary Transducer | Toshiba America Medical Systems, In.C | 1997 | — |
| +1 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| +2 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| +3 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +4 | K092756 | GE Vscan Compact Diagnostic Ultrasound System | Ge Vingmed Ultrasound AS | 2009 | — |
| +4 | K090505 | Speq Ultrasound System | Signostics Pty, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 8 | 0 |
| 2015 | 8 | 0 |
| 2016 | 11 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 18 | 1 |
| 2021 | 15 | 0 |
| 2022 | 15 | 0 |
| 2023 | 13 | 0 |
| 2024 | 12 | 0 |
| 2025 | 25 | 2 |
| 2026 | 19 | 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.
3 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? (3)
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 |
|---|---|---|---|
| * | K933743 | SSA-380ASummary page 1…avitary Transducer will be used with the SSA-380A diagnostic ultrasound system, which was cleared for cardiac, fetal, small organ and peripheral vascular applications in K933743 and abdominal organ imaging in K943303. The SSA-380A system software and hardware is only upgraded to recognize the addition of t… | 1994 |
| * | K943303 | PVK-357ATSummary page 1…e SSA-380A diagnostic ultrasound system, which was cleared for cardiac, fetal, small organ and peripheral vascular applications in K933743 and abdominal organ imaging in K943303. The SSA-380A system software and hardware is only upgraded to recognize the addition of the PVK-720ST Endocavitary Transducer. N… | 1995 |
| * | K891453 | Diagnostic Ultrasound Transducer: Pve-582VSummary page 1…720ST Endocavitary Transducer is similar to the PVE- 582V endocavitary transducer that was cleared for transvaginal use with the SSA-270A diagnostic ultrasound system in K891453. The PVK-720ST follows the same software verification and validation procedures and employs the same general technology as that… | 1989 |
What descends from it? (204)
See all 2041 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991710 | Ssa-370A/Powervision 6000 | 1999 | 203 |
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K193517ViziShot 2 FLEXOlympus Surgical Technologies America · 2020 · 8 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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/K964865 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964865: PVK-720ST Endocavitary Transducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964865
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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