510(k) · Cleared
ClearedUltramark 400C/Sonoace 6000 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Technology Laboratories, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Aug 23, 1999 as substantially equivalent to K974269 (Medison America, Inc., 1998) after a 28-day review. Its family tree reaches back 2 generations to 1997. 208 later devices descend from it.
- Decided
- Aug 23, 1999
- Review
- 28 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961459 (1997). 208 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK961459 Level 10 HdiAdvanced Technology Laboratories, Inc. · 1997
- 1 generation backK974269 SA8800 Diagnostic Ultrasound System and Transducers,Medison America, Inc. · 1998
- This deviceK992470 Ultramark 400C/Sonoace 6000 Ultrasound SystemAdvanced Technology Laboratories, 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 | K961459 | Level 10 Hdi | Advanced Technology Laboratories, Inc. | 1997 | — |
| −1 | K974269 | SA8800 Diagnostic Ultrasound System and Transducers, | Medison America, Inc. | 1998 | — |
| 0 (this device) | K992470 | Ultramark 400C/Sonoace 6000 Ultrasound System | Advanced Technology Laboratories, 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 | — |
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 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? (1)
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 |
|---|---|---|---|
| * | K974269 | SA8800 Diagnostic Ultrasound System and Transducers,Summary page 1…anced Technology Laboratories, Inc. believes that the UM 400C/ SA 6000C Ultrasound System is substantially equivalent to the currently marketed SA 8800/HDI® 1500 system (K974269). 510(k) Summary of Safety and Effectiveness Page 1 992470 vZ 74 510(k) Premarket Notification UM 400C/ SA 6000… | 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 2 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K002185 (Medison America, Inc., 2000) has gone furthest, with 207 descendants of its own.
- 7 other devices also cite its predicate K974269.
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:
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/K992470 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992470: Ultramark 400C/Sonoace 6000 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992470
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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