510(k) Report

510(k) · Cleared

Cleared

Aloka Model SSD-5500 V6.0 Ultrasound System

K032875510(k) TraditionalCleared Sep 30, 200315-day reviewClass II21 CFR 892.1560

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

Aloka Co. Ltd USA · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Sep 30, 2003 as substantially equivalent to K963616 (Aloka Co., Ltd., 1997) and 4 other predicates after a 15-day review. Its family tree reaches back 2 generations to 1996. 124 later devices descend from it.

Decided
Sep 30, 2003
Review
15 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K954022 (1996). 6 ancestors in all. 124 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 1 other ancestor1997: 1 other ancestor2004: 3 descendants cleared2011: 2 descendants cleared2013: 3 descendants cleared2006: 1 descendant cleared2009: 1 descendant cleared2007: 2 descendants cleared2010: 1 descendant cleared2016: 6 descendants cleared2014: 9 descendants cleared2012: 1 descendant cleared2008: 1 descendant cleared2020: 9 descendants cleared2019: 20 descendants cleared2023: 9 descendants cleared2017: 9 descendants cleared2018: 11 descendants cleared2025: 7 descendants cleared2026: 6 descendants cleared2021: 9 descendants cleared2022: 9 descendants cleared2024: 5 descendants clearedK954022 · Aloka Omniview Diagnostic Ultrasound System · Aloka Co., Ltd. · 1996K992663 · Aloka SSD-5500 Diagnostic Ultrasound System · Aloka Co., Ltd. · 19991995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 7 descendants2 generations forward: 14 descendants3 generations forward: 18 descendants4 generations forward: 10 descendants5 generations forward: 10 descendants6 generations forward: 15 descendants7 generations forward: 13 descendants8 generations forward: 11 descendants9 generations forward: 8 descendants10 generations forward: 6 descendants11 generations forward: 3 descendants12 generations forward: 2 descendants13 generations forward: 4 descendants14 generations forward: 2 descendants15 generations forward: 1 descendant K992663 · Aloka SSD-5500 Diagnostic Ultrasound System · Aloka Co., Ltd. · 1999K954022 · Aloka Omniview Diagnostic Ultrasound System · Aloka Co., Ltd. · 19960+5+10+15
  1. Root · 2 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
  2. 1 generation backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
  3. This deviceK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
  4. Descendant · cites it directly · 106 of its ownK043196 Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004
  5. Descendant · 2 generations on · 91 of its ownK110207 Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011
  6. Descendant · cites it directly · 87 of its ownK123828 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2013 · Recalled
  7. Descendant · 2 generations on · 60 of its ownK140639 Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd. · 2014
  8. Descendant · 3 generations on · 59 of its ownK153539 RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd. · 2016

Showing 5 of 124 descendants. See all descendants

Descendants cleared per year

2004: 32006: 12007: 22008: 12009: 12010: 12011: 22012: 12013: 32014: 92016: 62017: 92018: 112019: 202020: 92021: 92022: 92023: 92024: 52025: 72026: 6
2004high 20 (2019) · low 0 (2005)2026

Most influential descendants

Showing 5 of 124 · See all
  • K043196Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd. · 2004 · cites it directly106descendants
  • K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd. · 2011 · 2 generations on91descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K954022Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd.1996—
−1K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd.1999—
0 (this device)K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA2003—
+1K043196Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd.2004—
+2K110207Aloka Prousound F75 Diagnostic Ultrasound SystemAloka Co., Ltd.2011—
+1K123828Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.20131
+2K140639Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.2014—
+3K153539RS80A Diagnostic Ultrasound SystemSamsung Medison Co., Ltd.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200430
200610
200720
200810
200910
201010
201120
201210
201330
201490
201660
201790
2018110
2019200
202090
202190
202290
202390
202450
202570
202660
FIG. 1 — Lineage of K032875, 1996–2026Source: 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), 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 IYO? 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 IYO device

  1. #1 K243937 Accuro 3Sscore 20.5 · 18 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? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K963616Aloka SSD-1700 Diagnostic Ultrasound System
Summary page 1
…e Aloka SSD-5500 V6.0 diagnostic ultrasound system and transducers are similar in technological characteristics to Aloka’s initial predicate ultrasound system: SSD-1700 (K963616) as well as Aloka’s SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ KO1 1457) and SSD-5500 Ver. 4.2.2 (KO1 1315). 0 The…
Aloka Co., Ltd.1997—
*K992663Aloka SSD-5500 Diagnostic Ultrasound System
Summary page 1
…stem and transducers are similar in technological characteristics to Aloka’s initial predicate ultrasound system: SSD-1700 (K963616) as well as Aloka’s SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ KO1 1457) and SSD-5500 Ver. 4.2.2 (KO1 1315). 0 The SSD-5500 V6.0 is indicated for the same diagno…
Aloka Co., Ltd.1999—
*K002784Aloka Ust-5280-5
Summary page 1
…ilar in technological characteristics to Aloka’s initial predicate ultrasound system: SSD-1700 (K963616) as well as Aloka’s SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ KO1 1457) and SSD-5500 Ver. 4.2.2 (KO1 1315). 0 The SSD-5500 V6.0 is indicated for the same diagnostic ultrasound applications…
Aloka Co., Ltd.2000—
*K011457Aloka SSD-5500 with KI and a-SmaAloka Co., Ltd.2001—
*K011315SSD 5500 with Olympus GF Type UC140P-AL5Aloka Co., Ltd.2001—

Also cleared against K963616: 4 other devices →

What descends from it? (124)

See all 124

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

NumberDeviceApplicantDecidedDescendants
K043196Aloka SSD-Alpha 10 Ultrasound SystemAloka Co., Ltd.2004106
K123828Prosound F75 Diagnostic Ultrasound SystemHitachi Aloka Medical, Ltd.201387
K040719Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryAloka Co., Ltd.200427
K110688MylabgoldEsaote201125
K061961Art Lab SoftwarePie Medical200618
K041916Aloka SSD-Alpha 5 Ultrasound SystemAloka Co. Ltd USA200412
K122537Prousound Alpha 7 Ver. 6.0 Diagnostic Ultrasound System Model: Prosound Alpha 7 Ver. 6.0Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical20132

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 7 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K043196 (Aloka Co., Ltd., 2004) has gone furthest, with 106 descendants of its own.
  • 4 other devices also cite its predicate K963616.

How does its category compare?

All IYO devices

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

FDA decisions per year · IYO

7in 2025

2007: 202008: 142009: 132010: 152011: 112012: 152013: 172014: 142015: 192016: 102017: 192018: 142019: 132020: 112021: 152022: 52023: 112024: 102025: 72026 (partial year): 10
2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007: 17 days median2008: 36 days median2009: 79 days median2010: 113 days median2011: 69 days median2012: 68 days median2013: 50 days median2014: 63 days median2015: 46 days median2016: 36 days median2017: 72 days median2018: 56 days median2019: 59 days median2020: 57 days median2021: 64 days median2022: 190 days median2023: 177 days median2024: 220 days median2025: 171 days median2026 (partial year): 139 days median
2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

2007: 42008: 52009: 92010: 82012: 22013: 32014: 22015: 12018: 12019: 12021: 112022: 12026 (partial year): 1
2007high 11 (2021) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IYO

485in 2025

2007: 392008: 202009: 272010: 202011: 582012: 782013: 4362014: 3042015: 2682016: 2542017: 2382018: 3682019: 5372020: 4982021: 6172022: 5112023: 5272024: 6402025: 485
2007high 640 (2024) · low 20 (2008)2025

MAUDE reports naming product code IYO, 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
20072017439
20081436520
20091379927
201015113820
20111169058
20121568278
201317503436
201414632304
201519461268
201610360254
201719720238
201814561368
201913591537
202011570498
2021156411617
202251901511
2023111770527
2024102200640
202571710485
2026101391—

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.

Also cleared against K963616

4 other devices cite the same predicate.

  • K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
  • K981834Perception Inc, GPS-6TBMD Diagnostic Ultrasound SystemPerception, Inc. · 1998
  • K974880Perception GPS-RST Diagnostic Ultrasound SystemPerception, Inc. · 1998
  • K972973Perception Inc. GPS-Tuv Diagnostic Ultrasound SystemPerception, Inc. · 1997

More from Aloka Co. Ltd USA

2 FDA decisions under this applicant name. See the company

  • K041916Aloka SSD-Alpha 5 Ultrasound SystemAloka Co. Ltd USA · 2004

Recent decisions in IYO

The IYO category page

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  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K032875 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032875: Aloka Model SSD-5500 V6.0 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/K032875

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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