510(k) Report

510(k) · Cleared

Cleared

Aloka SSD-5500 with KI and a-Sma

K011457510(k) TraditionalCleared May 23, 200112-day reviewClass II21 CFR 892.1550

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Aloka Co., Ltd. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on May 23, 2001 after a 12-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 331 later devices descend from it.

Decided
May 23, 2001
Review
12 days
Class
Class II
Product code
IYN
Recalls
None
Predicates
0

331 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2001: 1 descendant cleared2004: 3 descendants cleared2002: 1 descendant cleared2006: 2 descendants cleared2007: 4 descendants cleared2011: 11 descendants cleared2013: 13 descendants cleared2009: 5 descendants cleared2010: 7 descendants cleared2016: 18 descendants cleared2012: 10 descendants cleared2018: 25 descendants cleared2008: 5 descendants cleared2015: 17 descendants cleared2014: 12 descendants cleared2020: 23 descendants cleared2019: 31 descendants cleared2023: 18 descendants cleared2017: 34 descendants cleared2025: 22 descendants cleared2026: 12 descendants cleared2022: 19 descendants cleared2024: 18 descendants cleared2021: 19 descendants cleared200020052010201520202025
  1. This deviceK011457 Aloka SSD-5500 with KI and a-SmaAloka Co., Ltd. · 2001
  2. Descendant · cites it directly · 207 of its ownK012080 SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001
  3. Descendant · 2 generations on · 189 of its ownK063500 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006
  4. Descendant · 2 generations on · 188 of its ownK072164 DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007
  5. Descendant · 3 generations on · 182 of its ownK080640 M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
  6. Descendant · 3 generations on · 180 of its ownK081320 DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008

Showing 5 of 331 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 12004: 32006: 22007: 42008: 52009: 52010: 72011: 112012: 102013: 132014: 122015: 172016: 182017: 342018: 252019: 312020: 232021: 192022: 192023: 182024: 182025: 222026: 12
2001high 34 (2017) · low 0 (2005)2026

Most influential descendants

Showing 5 of 331 · See all
  • K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2001 · cites it directly207descendants
  • K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2006 · 2 generations on189descendants
  • K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2007 · 2 generations on188descendants
  • K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on182descendants
  • K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 3 generations on180descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011457Aloka SSD-5500 with KI and a-SmaAloka Co., Ltd.2001—
+1K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd.2001—
+2K063500DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2006—
+2K072164DC-6 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2007—
+3K080640M5 Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008—
+3K081320DC-3, DC-3T Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200310
200430
200620
200740
200850
200950
201070
2011110
2012100
2013130
2014120
2015170
2016180
2017340
2018250
2019310
2020230
2021190
2022190
2023180
2024180
2025220
2026120
FIG. 1 — Lineage of K011457, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (331)

See all 331

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K012080SSD-5000 Diagnostic Ultrasound SystemAloka Co., Ltd.2001207
K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA2003124
K040719Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryAloka Co., Ltd.200427

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, K012080 (Aloka Co., Ltd., 2001) has gone furthest, with 207 descendants of its own.

How does its category compare?

All IYN devices

IYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYN

57in 2025

2007: 132008: 252009: 182010: 292011: 392012: 432013: 512014: 562015: 542016: 602017: 642018: 592019: 472020: 572021: 462022: 532023: 442024: 502025: 572026 (partial year): 44
2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007: 26 days median2008: 18 days median2009: 29 days median2010: 67 days median2011: 46 days median2012: 37 days median2013: 60 days median2014: 39 days median2015: 55 days median2016: 56 days median2017: 83 days median2018: 85 days median2019: 79 days median2020: 72 days median2021: 105 days median2022: 105 days median2023: 115 days median2024: 119 days median2025: 124 days median2026 (partial year): 107 days median
2007high 124 (2025) · low 18 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYN

10in 2025

2007: 162008: 122009: 82010: 102011: 82012: 32013: 82014: 22015: 32016: 22018: 72020: 42021: 82022: 102023: 42024: 12025: 102026 (partial year): 2, 1 Class I
2007high 16 (2007) · low 0 (2017)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · IYN

610in 2025

2007: 32008: 22009: 92010: 172011: 182012: 202013: 182014: 482015: 1162016: 1452017: 1462018: 852019: 592020: 672021: 2132022: 1862023: 2292024: 2662025: 610
2007high 610 (2025) · low 2 (2008)2025

MAUDE reports naming product code IYN, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071326163
20082518122
2009182989
201029671017
20113946818
20124337320
20135160818
20145639248
201554553116
201660562145
201764830146
20185985785
20194779059
20205772467
2021461058213
20225310510186
2023441154229
2024501191266
20255712410610
2026441072 (1)—

More from Aloka Co., Ltd.

39 FDA decisions under this applicant name. See the company

  • K111227Aloka SSD-3500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
  • K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
  • K093488Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2009
  • K083254Aloka Prousound 2 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2008
  • K081843Ultrasound Data Analysis System, Model Das-RS1Aloka Co., Ltd. · 2008

Recent decisions in IYN

The IYN category page

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  • K263150V10 Diagnostic Ultrasound System; cV10 Diagnostic Ultrasound System; H10 Diagnostic Ultrasound System; XV10…Samsung Medison Co., Ltd. · 2026
  • K261617Diagnostic Ultrasound System (Resona I10W);Diagnostic Ultrasound System (Resona I10 Exp);Diagnostic…Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2026
  • K261933Voluson Expert 18; Voluson Expert 20; Voluson Expert 22GE Medical Systems Ultrasound and Primary care Diagnostics, LLC · 2026
  • K262548EPIQ Inspira Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound SystemPhilips Ultrasound, LLC · 2026

https://510kreport.com/device/K011457 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011457: Aloka SSD-5500 with KI and a-Sma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011457

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026