510(k) · Cleared

Cleared

Sonoline Elegra Diagnostic Ultrasound System

K003125510(k) TraditionalCleared Oct 20, 200015-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

Siemens Medical Solutions USA, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic

Cleared on Oct 20, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 952 devices in its family, counting itself, have a Class I recall. 951 later devices descend from it.

Decided: Oct 20, 2000
Review: 15 days
Class: Class II
Product code: IYN
Recalls: None
Predicates: 0

951 later devices descend from it, 1 citing it directly. 2 of the 952 devices in this family, counting this one, have a Class I recall.

This deviceK003125 Sonoline Elegra Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2000
Descendant · cites it directly · 950 of its ownK040060 Sonoline G50 and G60 S 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 · 2 generations on · 921 of its ownK050034 Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · Recalled
Descendant · 2 generations on · 806 of its ownK052021 V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · Recalled

Showing 5 of 951 descendants. See all descendants

Descendants cleared per year

2004high 79 (2025) · low 3 (2004)2026

Class I recalls in this family

K242670 Lumify Diagnostic Ultrasound System11 generations on · 2025
K242519 Lumify Diagnostic Ultrasound System11 generations on · 2025

Most influential descendants

Showing 5 of 951 · See all

K040060Sonoline G50 and G60 S Diagnostic Ultrasound SystemsSiemens Medical Solutions USA, Inc. · 2004 · cites it directly950descendants
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
K050034Sonoline Antares Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on921descendants
K052021V5MS Transducer and MPT7-4 Multiplane Transesophageal TransducerSiemens Medical Solutions USA, Inc. · 2005 · 2 generations on806descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003125	Sonoline Elegra Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2000	—
+1	K040060	Sonoline G50 and G60 S 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
+2	K050034	Sonoline Antares Diagnostic Ultrasound System	Siemens Medical Solutions USA, Inc.	2005	1
+2	K052021	V5MS Transducer and MPT7-4 Multiplane Transesophageal Transducer	Siemens Medical Solutions USA, Inc.	2005	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	7	0
2006	7	0
2007	9	0
2008	9	0
2009	14	0
2010	18	0
2011	26	0
2012	32	0
2013	41	0
2014	45	0
2015	53	0
2016	59	0
2017	76	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 K003125, 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.

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

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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? (951)

See all 951

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K040060	Sonoline G50 and G60 S Diagnostic Ultrasound Systems	Siemens Medical Solutions USA, Inc.	2004	950

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

What does this lineage say?

Of its descendants, K040060 (Siemens Medical Solutions USA, Inc., 2004) has gone furthest, with 950 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/K003125 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003125: Sonoline Elegra Diagnostic Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003125

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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