510(k) · Cleared
ClearedVolusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · ITX Transducer, Ultrasonic, Diagnostic
Cleared on Jul 8, 1999 as substantially equivalent to K940942 (Medison America, Inc., 1997) and 1 other predicate after a 13-day review. Its family tree reaches back 2 generations to 1994. 208 later devices descend from it.
- Decided
- Jul 8, 1999
- Review
- 13 days
- Class
- Class II
- Product code
- ITX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933743 (1994). 3 ancestors in all. 208 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK933743 SSA-380AToshiba America Medical Systems, In.C · 1994
- 1 generation backK974813 Combison 530D with Power Doppler ModeMedison America, Inc. · 1998
- This deviceK992155 Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion…Medison America, Inc. · 1999
- Descendant · cites it directly · 207 of its ownK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 204 of its ownK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- Descendant · 2 generations on · 184 of its ownK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- Descendant · 3 generations on · 182 of its ownK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
- Descendant · 2 generations on · 132 of its ownK032329 SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003
Showing 5 of 208 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 208 · See all- K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · cites it directly207descendants
- K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001 · 2 generations on204descendants
- K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · 2 generations on184descendants
- K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004 · 3 generations on182descendants
- K032329SA 9900 Plus Diagnostic Ultrasound SystemMedison America, Inc. · 2003 · 2 generations on132descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933743 | SSA-380A | Toshiba America Medical Systems, In.C | 1994 | — |
| −1 | K974813 | Combison 530D with Power Doppler Mode | Medison America, Inc. | 1998 | — |
| 0 (this device) | K992155 | Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal… | Medison America, Inc. | 1999 | — |
| +1 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| +2 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| +2 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| +3 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
| +2 | K032329 | SA 9900 Plus Diagnostic Ultrasound System | Medison America, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 9 | 0 |
| 2012 | 5 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 5 | 0 |
| 2016 | 11 | 0 |
| 2017 | 15 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 11 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 10 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 8 | 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? (2)
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 |
|---|---|---|---|
| * | K940942 | Combison 530 Diagnostic Ultrasound ScannerSummary page 1…0. For Model S-VAW 4-7: Kretztechnik Transducer Models S-VSW 3-5 and S-ACA 4-7. The.three predicate devices were all cleared with the Combison 530D system under 510(k)'s K940942 and K974813. See also Combison 530D Special Report dated October 23, 1997. 4. DEVICE DESCRIPTION. General: Transducer S-VNW 5-10… | 1997 |
| * | K974813 | Combison 530D with Power Doppler ModeSummary page 1…S-VAW 4-7: Kretztechnik Transducer Models S-VSW 3-5 and S-ACA 4-7. The.three predicate devices were all cleared with the Combison 530D system under 510(k)'s K940942 and K974813. See also Combison 530D Special Report dated October 23, 1997. 4. DEVICE DESCRIPTION. General: Transducer S-VNW 5-10 is a multie… | 1998 |
What descends from it? (208)
See all 2081 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | 2000 | 207 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K002185 (Medison America, Inc., 2000) has gone furthest, with 207 descendants of its own.
- 2 other devices also cite its predicate K940942.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body
Diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992155 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992155: Volusion Small Parts Transducer, Model S-VNW 5-10, Volusion Abdominal Transducer, Model S-Vaw 4-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992155
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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