510(k) · Cleared
ClearedAloka SSD-5000 V5.0 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 Oct 29, 2003 after a 15-day review. The FDA summary names no predicate by number. 101 later devices descend from it.
- Decided
- Oct 29, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
101 later devices descend from it, 2 citing it directly.
- This deviceK033311 Aloka SSD-5000 V5.0 Ultrasound SystemAloka Co., Ltd. · 2003
- Descendant · cites it directly · 87 of its ownK123828 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 60 of its ownK140639 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2014
- Descendant · 3 generations on · 59 of its ownK153539 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016
- Descendant · 4 generations on · 58 of its ownK163691 HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017
- Descendant · 5 generations on · 39 of its ownK173204 RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K123828Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2013 · cites it directly87descendants
- K140639Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2014 · 2 generations on60descendants
- K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016 · 3 generations on59descendants
- K163691HS70A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2017 · 4 generations on58descendants
- K173204RS85 Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2018 · 5 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033311 | Aloka SSD-5000 V5.0 Ultrasound System | Aloka Co., Ltd. | 2003 | — |
| +1 | K123828 | Prosound F75 Diagnostic Ultrasound System | Hitachi Aloka Medical, Ltd. | 2013 | 1 |
| +2 | K140639 | Prosound F75 Diagnostic Ultrasound System | Hitachi Aloka Medical, Ltd. | 2014 | — |
| +3 | K153539 | RS80A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2016 | — |
| +4 | K163691 | HS70A Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2017 | — |
| +5 | K173204 | RS85 Diagnostic Ultrasound System | Samsung Medison Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 9 | 0 |
| 2018 | 10 | 0 |
| 2019 | 17 | 0 |
| 2020 | 7 | 0 |
| 2021 | 9 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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?
The FDA summary names no predicate by number.
What descends from it? (101)
See all 1012 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?
- Of its descendants, K123828 (Hitachi Aloka Medical, Ltd., 2013) has gone furthest, with 87 descendants of its own.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033311: Aloka SSD-5000 V5.0 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033311
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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