510(k) · Cleared

Recalled · 2010

Sonoline Antares with Clarify VE

K033196510(k) TraditionalCleared Oct 16, 200314-day reviewClass II21 CFR 892.1550Recalls 1

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. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 16, 2003 after a 14-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 991 devices in its family, counting itself, have a Class I recall. 990 later devices descend from it. It has been recalled once.

Decided: Oct 16, 2003
Review: 14 days
Class: Class II
Product code: IYN
Recalls: 1
Predicates: 0

990 later devices descend from it, 5 citing it directly. 2 of the 991 devices in this family, counting this one, have a Class I recall.

This deviceK033196 Sonoline Antares with Clarify VESiemens Medical Solutions USA, Inc. · 2003
Descendant · cites it directly · 988 of its ownK041319 Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004
Descendant · 2 generations on · 979 of its ownK051139 Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · 3 generations on · 972 of its ownK052410 Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005
Descendant · 2 generations on · 932 of its ownK042770 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · Recalled
Descendant · 3 generations on · 927 of its ownK050240 Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled

Showing 5 of 990 descendants. See all descendants

Descendants cleared per year

2004high 80 (2025) · low 3 (2004)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System9 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System9 generations on · 2025

Most influential descendants

Showing 5 of 990 · See all

K041319Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2004 · cites it directly988descendants
K051139Acuson Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on979descendants
K052410Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on972descendants
K042770Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2004 · 2 generations on932descendants
K050240Modification to Acuson CV70 Cardiovascular SystemSiemens Medical Solutions USA, Inc. · 2005 · 3 generations on927descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K033196	Sonoline Antares with Clarify VE	Siemens Medical Solutions USA, Inc.	2003	—
+1	K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	—
+2	K051139	Acuson Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+3	K052410	Acuson Sequoia Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	—
+2	K042770	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2004	1
+3	K050240	Modification to Acuson CV70 Cardiovascular System	Siemens Medical Solutions USA, Inc.	2005	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	5	0
2006	5	0
2007	11	0
2008	14	0
2009	21	0
2010	17	0
2011	29	0
2012	36	0
2013	42	0
2014	50	0
2015	59	0
2016	59	0
2017	77	0
2018	68	0
2019	49	0
2020	75	0
2021	54	0
2022	59	0
2023	57	0
2024	65	0
2025	80	2
2026	55	0

FIG. 1 — Lineage of K033196, 2003–2026Source: 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 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? (990)

See all 990

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

Number	Device	Applicant	Decided	Descendants
K041319	Sequoia Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	988
K043016	Sonoline Orchid Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2004	927
K063138	Modification to Acuson Antares Ultrasound System	Siemens Medical Solutions USA, Inc.	2006	802
K063803	Acuson Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc., Ultrasound DI	2007	801
K060992	Syngo US Workplace	Siemens Medical Solutions	2006	97

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 1, 2010	Not classified	Z-1853-2011	Software design	Image captured from the device may be erroneous.

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 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall
K242519Lumify Diagnostic Ultrasound SystemPhilips Ultrasound · 2025 · 9 generations on · ◆ in the 2025 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K041319 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 988 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/K033196 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033196: Sonoline Antares with Clarify VE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033196

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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