510(k) · Cleared
ClearedSonoace 5500 Diagnostic Ultrasound System
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 Sep 1, 1999 as substantially equivalent to K990970 (Medison America, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 3 generations to 1993. 33 later devices descend from it.
- Decided
- Sep 1, 1999
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K924432 (1993). 7 ancestors in all. 33 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK924432 Medison 1500Medison Co., Ltd. · 1993
- 2 generations backK981510 Sonoace 6000/ Ultramark 400Medison America, Inc. · 1998
- 1 generation backK990970 Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also…Medison America, Inc. · 1999
- This deviceK992761 Sonoace 5500 Diagnostic Ultrasound SystemMedison America, Inc. · 1999
- Descendant · cites it directly · 32 of its ownK012887 SA6000II Diagnostic Ultrasound SystemMedison America, Inc. · 2001
- Descendant · 2 generations on · 30 of its ownK043588 Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005
- Descendant · 3 generations on · 29 of its ownK053154 MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005
- Descendant · 3 generations on · 28 of its ownK061755 MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006
- Descendant · 3 generations on · 27 of its ownK070903 MYLAB40Esaote Europe B.V. · 2007
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K012887SA6000II Diagnostic Ultrasound SystemMedison America, Inc. · 2001 · cites it directly32descendants
- K043588Mylab 15 / Mylab 20, Model 2700Pie Medical · 2005 · 2 generations on30descendants
- K053154MYLAB15/20 3D/4D Ultrasound Imaging SystemPie Medical · 2005 · 3 generations on29descendants
- K061755MYLAB15/20 New Indications Ultrasound SystemEsaote Europe B.V. · 2006 · 3 generations on28descendants
- K070903MYLAB40Esaote Europe B.V. · 2007 · 3 generations on27descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924432 | Medison 1500 | Medison Co., Ltd. | 1993 | — |
| −2 | K981510 | Sonoace 6000/ Ultramark 400 | Medison America, Inc. | 1998 | — |
| −1 | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called… | Medison America, Inc. | 1999 | — |
| 0 (this device) | K992761 | Sonoace 5500 Diagnostic Ultrasound System | Medison America, Inc. | 1999 | — |
| +1 | K012887 | SA6000II Diagnostic Ultrasound System | Medison America, Inc. | 2001 | — |
| +2 | K043588 | Mylab 15 / Mylab 20, Model 2700 | Pie Medical | 2005 | — |
| +3 | K053154 | MYLAB15/20 3D/4D Ultrasound Imaging System | Pie Medical | 2005 | — |
| +3 | K061755 | MYLAB15/20 New Indications Ultrasound System | Esaote Europe B.V. | 2006 | — |
| +3 | K070903 | MYLAB40 | Esaote Europe B.V. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K990970 | Sonoace 6000C Diagnostic Ultrasound System and Transducers, Also Called Ultrasound…Summary page 1…gally marketed device: Medison America, Inc. believes that SA 5500 Ultrasound System is substantially equivalent to the currently marketed SonoAce 6000C/UM 400 systems (K990970) and Voluson 530D (K974813). Device Description: The SA 5500 System is a general purpose, mobile, software controlled, diagnost… | 1999 |
| * | K974813 | Combison 530D with Power Doppler ModeSummary page 1…ison America, Inc. believes that SA 5500 Ultrasound System is substantially equivalent to the currently marketed SonoAce 6000C/UM 400 systems (K990970) and Voluson 530D (K974813). Device Description: The SA 5500 System is a general purpose, mobile, software controlled, diagnostic ultrasound 510{k) Suorr… | 1998 |
| † | K940942 | Combison 530 Diagnostic Ultrasound Scanner | 1997 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012887 | SA6000II Diagnostic Ultrasound System | 2001 | 32 |
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 6 years and passes through 2 companies; a new generation was cleared every 11 months on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K012887 (Medison America, Inc., 2001) has gone furthest, with 32 descendants of its own.
- 1 other device also cites its predicate K990970.
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:
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/K992761 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992761: Sonoace 5500 Diagnostic 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/K992761
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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