510(k) · Cleared
ClearedAloka SSD-3500 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 May 13, 2011 as substantially equivalent to K060059 (Aloka Co., Ltd., 2006) after an 11-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- May 13, 2011
- Review
- 11 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K003739 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK003739 Aloka SSD-4000Aloka Co., Ltd. · 2000
- 2 generations backK023996 Aloka SSD-3500 Ultrasound SystemAloka Co., Ltd. · 2002
- 1 generation backK060059 Aloka SD-3500 Ultrasound SystemAloka Co., Ltd. · 2006
- This deviceK111227 Aloka SSD-3500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK152126 Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc. · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152126Ust-5550-R; Ust-5536-R; L43KHitachi Aloka Medical America, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K003739 | Aloka SSD-4000 | Aloka Co., Ltd. | 2000 | — |
| −2 | K023996 | Aloka SSD-3500 Ultrasound System | Aloka Co., Ltd. | 2002 | — |
| −1 | K060059 | Aloka SD-3500 Ultrasound System | Aloka Co., Ltd. | 2006 | — |
| 0 (this device) | K111227 | Aloka SSD-3500 Diagnostic Ultrasound System | Aloka Co., Ltd. | 2011 | — |
| +1 | K152126 | Ust-5550-R; Ust-5536-R; L43K | Hitachi Aloka Medical America, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K060059 | Aloka SD-3500 Ultrasound SystemSummary page 1…: The Aloka SSD-3500 Ver. 7.8 is technically comparable and substantially equivalent to the current Aloka SSD-3500 Ver. 7.0 -(K060059). It has the same technological characteristics, key safety and effectiveness features, and has the same in… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152126 | Ust-5550-R; Ust-5536-R; L43K | 2016 | 0 |
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 11 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K152126 (Hitachi Aloka Medical America, Inc., 2016) has gone furthest, with 0 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. 2011, this device’s year, is highlighted.
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 device is intended for use by a qualified physician for ultrasound evaluation of Small Parts, Abdominal, Cardiac, Peripheral Vascular, Fetal, Intra-operative, Intra-operative (Cardiac), Trans-vaginal, Trans-rectal, Gynecological, Pediatric, Laparoscopic, and Neonatal Cephalic applications.
The device is not indicated for Ophthalmic applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111227: Aloka SSD-3500 Diagnostic 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/K111227
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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