510(k) · Cleared
ClearedSonoace 6000/ Ultramark 400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medison America, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 8, 1998 as substantially equivalent to K924432 (Medison Co., Ltd., 1993) and 1 other predicate after a 10-day review. Its family tree reaches back 1 generation to 1993. 212 later devices descend from it.
- Decided
- May 8, 1998
- Review
- 10 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924432 (1993). 2 ancestors in all. 212 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK924432 Medison 1500Medison Co., Ltd. · 1993
- This deviceK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- Descendant · cites it directly · 209 of its ownK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- Descendant · 2 generations on · 207 of its ownK002185 Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · Recalled
- Descendant · 3 generations on · 204 of its ownK013627 Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- Descendant · 3 generations on · 184 of its ownK031552 Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · Recalled
- Descendant · 4 generations on · 182 of its ownK043455 SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004
Showing 5 of 212 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 212 · See all- K990970Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound…Medison America, Inc. · 1999 · cites it directly209descendants
- K002185Sonoace SA 9900 Diagnostic Ultrasound SystemMedison America, Inc. · 2000 · 2 generations on207descendants
- K013627Sonoace SA-8000 Diagnostic Ultrasound SystemMedison America, Inc. · 2001 · 3 generations on204descendants
- K031552Mycolor 202 Diagnostic Ultrasound System and TransducersMedison America, Inc. · 2003 · 3 generations on184descendants
- K043455SA8000 SE Diagnostic Ultrasound SystemMedison Co., Ltd. · 2004 · 4 generations on182descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| 0 (this device) | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| +1 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| +2 | K002185 | Sonoace SA 9900 Diagnostic Ultrasound System | Medison America, Inc. | 2000 | 1 |
| +3 | K013627 | Sonoace SA-8000 Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| +3 | K031552 | Mycolor 202 Diagnostic Ultrasound System and Transducers | Medison America, Inc. | 2003 | 5 |
| +4 | K043455 | SA8000 SE Diagnostic Ultrasound System | Medison Co., Ltd. | 2004 | — |
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 |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 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 IYO? 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? (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 |
|---|---|---|---|
| * | K924432 | Medison 1500Summary page 1…dicate or legally marketed device: ) Medison America, Inc believes that SA 6000 Ultrasound system is substantially equivalent to the currently marketed Medison SA 1500, K924432 and ATL Level 10 HDI Ultrasound, K961459 diagnostic ultrasound systems. 510(k) Summary of Safety and Effectiveness 0 A/ Page 1… | 1993 |
| * | K961459 | Level 10 HdiSummary page 1…ison America, Inc believes that SA 6000 Ultrasound system is substantially equivalent to the currently marketed Medison SA 1500, K924432 and ATL Level 10 HDI Ultrasound, K961459 diagnostic ultrasound systems. 510(k) Summary of Safety and Effectiveness 0 A/ Page 1 =i/ I\ 510(k) Premarket N… | 1997 |
What descends from it? (212)
See all 2122 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K990970 (Medison America, Inc., 1999) has gone furthest, with 209 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 | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow…
Read the full statement (117 words)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
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/K981510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981510: Sonoace 6000/ Ultramark 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981510
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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