510(k) · Cleared
ClearedDiagnostic Ultrasound Transducer: Pve-582V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshiba Medical Systems · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 1, 1989 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 of the 206 devices in its family, counting itself, have a Class I recall. 205 later devices descend from it.
- Decided
- Jun 1, 1989
- Review
- 78 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
205 later devices descend from it, 1 citing it directly. 3 of the 206 devices in this family, counting this one, have a Class I recall.
- This deviceK891453 Diagnostic Ultrasound Transducer: Pve-582VToshiba Medical Systems · 1989
- Descendant · cites it directly · 204 of its ownK964865 PVK-720ST Endocavitary TransducerToshiba America Medical Systems, In.C · 1997
- Descendant · 2 generations on · 203 of its ownK991710 Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999
- Descendant · 3 generations on · 196 of its ownK994096 Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999
- Descendant · 4 generations on · 135 of its ownK063761 Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 5 generations on · 130 of its ownK092756 GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 205 · See all- K964865PVK-720ST Endocavitary TransducerToshiba America Medical Systems, In.C · 1997 · cites it directly204descendants
- K991710Ssa-370A/Powervision 6000Toshiba America Medical Systems, In.C · 1999 · 2 generations on203descendants
- K994096Sonoheart Hand-Carried Echocardiography SystemSonosite,Inc. · 1999 · 3 generations on196descendants
- K063761Acuson P10 Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on135descendants
- K092756GE Vscan Compact Diagnostic Ultrasound SystemGe Vingmed Ultrasound AS · 2009 · 5 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891453 | Diagnostic Ultrasound Transducer: Pve-582V | Toshiba Medical Systems | 1989 | — |
| +1 | K964865 | PVK-720ST Endocavitary Transducer | Toshiba America Medical Systems, In.C | 1997 | — |
| +2 | K991710 | Ssa-370A/Powervision 6000 | Toshiba America Medical Systems, In.C | 1999 | — |
| +3 | K994096 | Sonoheart Hand-Carried Echocardiography System | Sonosite,Inc. | 1999 | — |
| +4 | K063761 | Acuson P10 Diagnostic Ultrasound System | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +5 | K092756 | GE Vscan Compact Diagnostic Ultrasound System | Ge Vingmed Ultrasound AS | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 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), 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (205)
See all 2051 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K964865 | PVK-720ST Endocavitary Transducer | 1997 | 204 |
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 · 9 generations on · ◆ in the 2020 descendants bar of FIG. 11 Class I recall
- K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
- K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K964865 (Toshiba America Medical Systems, In.C, 1997) has gone furthest, with 204 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
https://510kreport.com/device/K891453 · printed Nov 5, 2026
Cite this page
510(k) Report. “K891453: Diagnostic Ultrasound Transducer: Pve-582V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K891453
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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