510(k) · Cleared

Cleared

Siemens Sonoline 4XX

K946179510(k) TraditionalCleared Oct 3, 1995288-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

Siemens Medical Solutions USA, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic

Cleared on Oct 3, 1995 after a 288-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 932 devices in its family, counting itself, have a Class I recall. 931 later devices descend from it.

Decided: Oct 3, 1995
Review: 288 days
Class: Class II
Product code: IYO
Recalls: None
Predicates: 0

931 later devices descend from it, 3 citing it directly. 2 of the 932 devices in this family, counting this one, have a Class I recall.

This deviceK946179 Siemens Sonoline 4XXSiemens Medical Solutions USA, Inc. · 1995
Descendant · cites it directly · 930 of its ownK040502 Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
Descendant · cites it directly · 928 of its ownK042833 Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004
Descendant · 2 generations on · 927 of its ownK043016 Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · 2 generations on · 926 of its ownK052894 Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · 3 generations on · 802 of its ownK063138 Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006

Showing 5 of 931 descendants. See all descendants

Descendants cleared per year

2004high 79 (2025) · low 1 (2005)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System12 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System12 generations on · 2025

Most influential descendants

Showing 5 of 931 · See all

K040502Sonoline Ebisu Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly930descendants
K042833Sonoline G20 Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly928descendants
K043016Sonoline Orchid Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on927descendants
K052894Sonoline G60 S Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on926descendants
K063138Modification to Acuson Antares Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on802descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K946179	Siemens Sonoline 4XX	Siemens Medical Solutions USA, Inc.	1995	—
+1	K040502	Sonoline Ebisu Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	—
+1	K042833	Sonoline G20 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	—
+2	K043016	Sonoline Orchid Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
+2	K052894	Sonoline G60 S Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	1
+3	K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	1	0
2006	3	0
2007	7	0
2008	8	0
2009	13	0
2010	15	0
2011	26	0
2012	30	0
2013	41	0
2014	45	0
2015	53	0
2016	59	0
2017	75	0
2018	65	0
2019	49	0
2020	73	0
2021	53	0
2022	57	0
2023	57	0
2024	65	0
2025	79	2
2026	54	0

FIG. 1 — Lineage of K946179, 1995–2026Source: 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.

2 devices in this family have a Class I recall. 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 K243937 Accuro 3Sscore 20.5 · 18 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? (931)

See all 931

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

Number	Device	Applicant	Decided	Descendants
K040502	Sonoline Ebisu Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	930
K042833	Sonoline G20 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	928
K071314	Sonoline G20 Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2007	0

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K242670Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 12 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K040502 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 930 descendants of its own.

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

2007high 20 (2007) · low 5 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYO

171in 2025

2007high 220 (2024) · low 17 (2007)2026

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

Recalls per year · IYO

1in 2022

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	20	17	4	39
2008	14	36	5	20
2009	13	79	9	27
2010	15	113	8	20
2011	11	69	0	58
2012	15	68	2	78
2013	17	50	3	436
2014	14	63	2	304
2015	19	46	1	268
2016	10	36	0	254
2017	19	72	0	238
2018	14	56	1	368
2019	13	59	1	537
2020	11	57	0	498
2021	15	64	11	617
2022	5	190	1	511
2023	11	177	0	527
2024	10	220	0	640
2025	7	171	0	485
2026	10	139	1	—

https://510kreport.com/device/K946179 · printed Nov 4, 2026

Cite this page

510(k) Report. “K946179: Siemens Sonoline 4XX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K946179

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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