510(k) · Cleared

Cleared

Aloka SSD-4000

K003739510(k) AbbreviatedCleared Dec 27, 200023-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 Dec 27, 2000 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.

Decided: Dec 27, 2000
Review: 23 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

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

This deviceK003739 Aloka SSD-4000Aloka Co., Ltd. · 2000
Descendant · cites it directly · 27 of its ownK040719 Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional…Aloka Co., Ltd. · 2004
Descendant · cites it directly · 25 of its ownK110688 MylabgoldEsaote · 2011 · Recalled
Descendant · 2 generations on · 22 of its ownK132231 Mylabseven, MylabalphaEsaote, S.p.A. · 2013
Descendant · 2 generations on · 19 of its ownK142008 Mylabseven, MylabalphaEsaote, S.p.A. · 2014 · Recalled
Descendant · 3 generations on · 12 of its ownK153277 6200 Ultrasound System and 6250 Ultrasound SystemEsaote, S.p.A. · 2016

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2002high 5 (2016) · low 0 (2003)2026

Most influential descendants

Showing 5 of 32 · See all

K040719Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System AccessoryAloka Co., Ltd. · 2004 · cites it directly27descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003739	Aloka SSD-4000	Aloka Co., Ltd.	2000	—
+1	K040719	Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D…	Aloka Co., Ltd.	2004	—
+1	K110688	Mylabgold	Esaote	2011	1
+2	K132231	Mylabseven, Mylabalpha	Esaote, S.p.A.	2013	—
+2	K142008	Mylabseven, Mylabalpha	Esaote, S.p.A.	2014	3
+3	K153277	6200 Ultrasound System and 6250 Ultrasound System	Esaote, S.p.A.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2004	1	0
2006	1	0
2009	1	0
2011	2	0
2012	1	0
2013	1	0
2014	4	0
2016	5	0
2017	3	0
2018	2	0
2019	4	0
2021	1	0
2023	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K003739, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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? (32)

See all 32

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

Number	Device	Applicant	Decided	Descendants
K040719	Aloka Model SSD-4000 Diagnostic Ultrasound System W/Optional Sonoreal 3D System Accessory	Aloka Co., Ltd.	2004	27
K110688	Mylabgold	Esaote	2011	25
K023996	Aloka SSD-3500 Ultrasound System	Aloka Co., Ltd.	2002	3

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, K040719 (Aloka Co., Ltd., 2004) has gone furthest, with 27 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

2007high 64 (2017) · low 13 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYN

124in 2025

2007high 124 (2025) · low 18 (2008)2026

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

Recalls per year · IYN

10in 2025

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

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

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)	—

https://510kreport.com/device/K003739 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003739: Aloka SSD-4000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003739

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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