510(k) · Cleared
ClearedAloka SSD-Alpha 10 Ultrasound System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aloka Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Nov 30, 2004 as substantially equivalent to K032875 (Aloka Co. Ltd USA, 2003) after a 12-day review. Its family tree reaches back 3 generations to 1996. 106 later devices descend from it.
- Decided
- Nov 30, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K954022 (1996). 7 ancestors in all. 106 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
- 2 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
- 1 generation backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
- This deviceK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
- Descendant · cites it directly · 91 of its ownK110207 Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
- Descendant · 2 generations on · 87 of its ownK123828 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 60 of its ownK140639 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2014
- Descendant · 4 generations on · 59 of its ownK153539 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 5 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011 · cites it directly91descendants
- K123828Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2013 · 2 generations on87descendants
- K140639Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2014 · 3 generations on60descendants
- K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 4 generations on59descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 5 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K954022 | Aloka Omniview Diagnostic Ultrasound System | Aloka Co., Ltd. | 1996 | — |
| −2 | K992663 | Aloka SSD-5500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1999 | — |
| −1 | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound System | Aloka Co. Ltd USA | 2003 | — |
| 0 (this device) | K043196 | Aloka SSD-Alpha 10 Ultrasound System | Aloka Co., Ltd. | 2004 | — |
| +1 | K110207 | Aloka Prousound F75 Diagnostic Ultrasound System | Aloka Co., Ltd. | 2011 | — |
| +2 | K123828 | Prosound F75 Diagnostic Ultrasound System | Hitachi Aloka Medical, Ltd. | 2013 | 1 |
| +3 | K140639 | Prosound F75 Diagnostic Ultrasound System | Hitachi Aloka Medical, Ltd. | 2014 | — |
| +4 | K153539 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +5 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 9 | 0 |
| 2018 | 11 | 0 |
| 2019 | 17 | 0 |
| 2020 | 9 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 6 | 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 IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K032875 | Aloka Model SSD-5500 V6.0 Ultrasound SystemSummary page 1…,1560 & 1550, has been classified as regulatory Class II. The Aloka SSD- Alpha 10 and its transducers are substantially equivalent to its predicate; the Aloka SSD-5500 (K032875) and its transducers. The Aloka SSD-Alpha 10 functions in the same manner as its predicate and other Aloka diagnostic ultrasound… | 2003 |
What descends from it? (106)
See all 1064 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110207 | Aloka Prousound F75 Diagnostic Ultrasound System | 2011 | 91 |
| K070983 | Olympus XBF-UC180F-DT8 Ultrasonic Bronchofibervideoscope Used with Aloka SSD-Alpha 5/10… | 2007 | 11 |
| K072285 | Aloka SSD-Alpha 7 Ultrasound System | 2007 | 3 |
| K093395 | Olympus GF Type UC180, Olympus GF Type UCT180 Evis Exera II Ulatrasound Gastrovideoscope | 2010 | 1 |
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 8 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K110207 (Aloka Co., Ltd., 2011) has gone furthest, with 91 descendants of its own.
- 6 other devices also cite its predicate K032875.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043196 · printed Nov 3, 2026
Cite this page
510(k) Report. “K043196: Aloka SSD-Alpha 10 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K043196
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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