510(k) Report

510(k) · Cleared

Cleared

Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory

K040719510(k) TraditionalCleared Mar 26, 20047-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. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Mar 26, 2004 as substantially equivalent to K003739 (Aloka Co., Ltd., 2000) and 5 other predicates after a 7-day review. Its family tree reaches back 3 generations to 1996. 27 later devices descend from it.

Decided
Mar 26, 2004
Review
7 days
Class
Class II
Product code
IYO
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K954022 (1996). 8 ancestors in all. 27 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 2 other ancestors1997: 1 other ancestor2011: 1 descendant cleared2009: 1 descendant cleared2016: 4 descendants cleared2014: 4 descendants cleared2012: 1 descendant cleared2013: 1 descendant cleared2019: 4 descendants cleared2018: 2 descendants cleared2017: 3 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared2025: 3 descendants cleared2026: 1 descendant clearedK954022 · Aloka Omniview Diagnostic Ultrasound System · Aloka Co., Ltd. · 1996K992663 · Aloka SSD-5500 Diagnostic Ultrasound System · Aloka Co., Ltd. · 1999K032875 · Aloka Model SSD-5500 V6.0 Ultrasound System · Aloka Co. Ltd USA · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 5 descendants3 generations forward: 8 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 3 descendants8 generations forward: 2 descendants K032875 · Aloka Model SSD-5500 V6.0 Ultrasound System · Aloka Co. Ltd USA · 2003K992663 · Aloka SSD-5500 Diagnostic Ultrasound System · Aloka Co., Ltd. · 1999K954022 · Aloka Omniview Diagnostic Ultrasound System · Aloka Co., Ltd. · 19960+5
  1. Root · 3 generations backK954022 Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd. · 1996
  2. 2 generations backK992663 Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd. · 1999
  3. 1 generation backK032875 Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA · 2003
  4. This deviceK040719 Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional…Aloka Co., Ltd. · 2004
  5. Descendant · cites it directly · 25 of its ownK110688 MylabgoldEsaote · 2011 · Recalled
  6. Descendant · 2 generations on · 22 of its ownK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
  7. Descendant · 2 generations on · 19 of its ownK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · Recalled
  8. Descendant · 3 generations on · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016
  9. Descendant · 4 generations on · 9 of its ownK163082 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · Recalled

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 12013: 12014: 42016: 42017: 32018: 22019: 42021: 12023: 12025: 32026: 1
2009high 4 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 27 · See all
  • K110688MylabgoldEsaote · 2011 · cites it directly25descendants
  • K132231Mylabseven, MylabalphaEsaote, S.p.A. · 2013 · 2 generations on22descendants
  • K142008Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · 2 generations on19descendants
  • K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016 · 3 generations on12descendants
  • K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2017 · 4 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K954022Aloka Omniview Diagnostic Ultrasound SystemAloka Co., Ltd.1996—
−2K992663Aloka SSD-5500 Diagnostic Ultrasound SystemAloka Co., Ltd.1999—
−1K032875Aloka Model SSD-5500 V6.0 Ultrasound SystemAloka Co. Ltd USA2003—
0 (this device)K040719Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D…Aloka Co., Ltd.2004—
+1K110688MylabgoldEsaote20111
+2K132231Mylabseven, MylabalphaEsaote, S.p.A.2013—
+2K142008Mylabseven, MylabalphaEsaote, S.p.A.20143
+3K1532776200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.2016—
+4K1630826200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A.20172

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200020
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201210
201310
201440
201640
201730
201820
201940
202110
202310
202530
202610
FIG. 1 — Lineage of K040719, 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? (6)

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
*K003739Aloka SSD-4000
Summary page 1
…has been classified as regulatory Class II. The Aloka SSD-4000 Ver. 3.1 and its transducers are substantially equivalent to its predicates; the Aloka SSD-4000 Ver. 1.0 (K003739) and SSD-5500 -(K992663), (K002784), (KO0 1457), (KO0 1315) & (K032875) and their transducers. The Aloka SSD-4000 Ver.3.1 functio…
Aloka Co., Ltd.2000—
*K992663Aloka SSD-5500 Diagnostic Ultrasound System
Summary page 1
…regulatory Class II. The Aloka SSD-4000 Ver. 3.1 and its transducers are substantially equivalent to its predicates; the Aloka SSD-4000 Ver. 1.0 (K003739) and SSD-5500 -(K992663), (K002784), (KO0 1457), (KO0 1315) & (K032875) and their transducers. The Aloka SSD-4000 Ver.3.1 functions in the same manner as…
Aloka Co., Ltd.1999—
*K002784Aloka Ust-5280-5
Summary page 1
…Class II. The Aloka SSD-4000 Ver. 3.1 and its transducers are substantially equivalent to its predicates; the Aloka SSD-4000 Ver. 1.0 (K003739) and SSD-5500 -(K992663), (K002784), (KO0 1457), (KO0 1315) & (K032875) and their transducers. The Aloka SSD-4000 Ver.3.1 functions in the same manner as its predic…
Aloka Co., Ltd.2000—
*K011457Aloka SSD-5500 with KI and a-Sma
Summary page 1
…cal characteristics to Aloka's initial predicate ultrasound system: SSD-4000 Ver. 1.0 (K003739) as well as Aloka's SSD-5500 Ver.3.1 (K992663), SSD-5500 Ver.4.2 (K002784/ K011457), SSD-5500 Ver. 4.2.2 (KOI 1315) and SSD-5500 Ver. 6.0 (K032875). · The SSD-4000 Ver. 3.1 is indicated for the same diagnostic ul…
Aloka Co., Ltd.2001—
*K011315SSD 5500 with Olympus GF Type UC140P-AL5
Our reading of the summary gave K001315, FDA’s number for Modification to Kion Anesthesia System (Siemens Elema AB). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Aloka SSD-5500 Ver. 4.2.2”.
Aloka Co., Ltd.2001—
*K032875Aloka Model SSD-5500 V6.0 Ultrasound System
Summary page 1
…1 and its transducers are substantially equivalent to its predicates; the Aloka SSD-4000 Ver. 1.0 (K003739) and SSD-5500 -(K992663), (K002784), (KO0 1457), (KO0 1315) & (K032875) and their transducers. The Aloka SSD-4000 Ver.3.1 functions in the same manner as its predicates and other diagnostic ultrasound…
Aloka Co. Ltd USA2003—

Also cleared against K003739: 2 other devices →

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K110688MylabgoldEsaote201125
K093488Aloka Prosound Alpha 6 Diagnostic Ultrasound SystemAloka Co., Ltd.20090

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 8 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K110688 (Esaote, 2011) has gone furthest, with 25 descendants of its own.
  • 2 other devices also cite its predicate K003739.

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 K003739

2 other devices cite the same predicate.

  • K110688MylabgoldEsaote · 20111 recall
  • K023996Aloka SSD-3500 Ultrasound SystemAloka Co., Ltd. · 2002

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 IYO

The IYO category page

  • K262093Accuro XVRivanna Medical, Inc. · 2026
  • K260605Lilium one (USM330)Lilium Otsuka Co., Ltd. · 2026
  • K260313MD-6000S Bladder ScannerMEDA Co., Ltd. · 2026
  • K253452Accuro 3SRivanna Medical, Inc. · 2026
  • K260190ArthurROPCA ApS · 2026

https://510kreport.com/device/K040719 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040719: Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040719

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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