510(k) · Cleared
ClearedAloka SSD-1400 Diagnostic 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 Aug 15, 1997 after a 45-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Aug 15, 1997
- Review
- 45 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK972465 Aloka SSD-1400 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1997
- Descendant · cites it directly · 1 of its ownK012253 SSD-1000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001
- Descendant · cites it directly · 0 of its ownK080176 Aloka Prosound 6 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2008
- Descendant · 2 generations on · 0 of its ownK020668 Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003…Aloka Co., Ltd. · 2002
Most influential descendants
Showing 3 of 3 · See all- K012253SSD-1000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001 · cites it directly1descendant
- K080176Aloka Prosound 6 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2008 · cites it directly0descendants
- K020668Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124Aloka Co., Ltd. · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972465 | Aloka SSD-1400 Diagnostic Ultrasound System | Aloka Co., Ltd. | 1997 | — |
| +1 | K012253 | SSD-1000 Diagnostic Ultrasound System | Aloka Co., Ltd. | 2001 | — |
| +1 | K080176 | Aloka Prosound 6 Diagnostic Ultrasound System | Aloka Co., Ltd. | 2008 | — |
| +2 | K020668 | Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124 | Aloka Co., Ltd. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | — | Aloka SSD-1700 Named without a submission number | |
| * | — | Aloka Omniview diagnostic ultrasound systems and transducers Named without a submission number |
What descends from it? (3)
2 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, K012253 (Aloka Co., Ltd., 2001) has gone furthest, with 1 descendant 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?
The Aloka SSD-1400, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.
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/K972465 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972465: Aloka SSD-1400 Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972465
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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