510(k) · Cleared

Recalled · 2004

Somatom Emotion MS

K003014510(k) TraditionalCleared Oct 12, 200015-day reviewClass II21 CFR 892.1750Recalls 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. · JAK System, X-Ray, Tomography, Computed

Cleared on Oct 12, 2000 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 31 later devices descend from it. It has been recalled once.

Decided: Oct 12, 2000
Review: 15 days
Class: Class II
Product code: JAK
Recalls: 1
Predicates: 0

31 later devices descend from it, 1 citing it directly.

This deviceK003014 Somatom Emotion MSSiemens Medical Solutions USA, Inc. · 2000
Descendant · cites it directly · 30 of its ownK042328 Somatom SpiritSiemens Medical Systems, Inc. · 2004 · Recalled
Descendant · 2 generations on · 29 of its ownK140912 Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Descendant · 3 generations on · 27 of its ownK142955 SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge…Siemens Medical Solutions USA, Inc. · 2015 · Recalled
Descendant · 4 generations on · 24 of its ownK161196 SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · Recalled
Descendant · 4 generations on · 21 of its ownK162302 Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · Recalled

Showing 5 of 31 descendants. See all descendants

Descendants cleared per year

2004high 4 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 31 · See all

K042328Somatom SpiritSiemens Medical Systems, Inc. · 2004 · cites it directly30descendants
K140912Somatom Scope/Somatom Scope PowerSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on29descendants
K142955SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition…Siemens Medical Solutions USA, Inc. · 2015 · 3 generations on27descendants
K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. · 2016 · 4 generations on24descendants
K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. · 2016 · 4 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003014	Somatom Emotion MS	Siemens Medical Solutions USA, Inc.	2000	—
+1	K042328	Somatom Spirit	Siemens Medical Systems, Inc.	2004	2
+2	K140912	Somatom Scope/Somatom Scope Power	Siemens Medical Solutions USA, Inc.	2014	2
+3	K142955	SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM…	Siemens Medical Solutions USA, Inc.	2015	16
+4	K161196	SOMATOM Drive	Siemens Medical Solutions USA, Inc.	2016	4
+4	K162302	Somatom Confidence ® RT Pro	Siemens Medical Solutions USA, Inc.	2016	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2014	1	0
2015	1	0
2016	3	0
2017	3	0
2018	2	0
2019	3	0
2020	2	0
2021	2	0
2022	1	0
2023	3	0
2024	3	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K003014, 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 JAK? 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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? (31)

See all 31

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

Number	Device	Applicant	Decided	Descendants
K042328	Somatom Spirit	Siemens Medical Systems, Inc.	2004	30

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 28, 2004	Not classified	Z-0156-05	Other	Calcium Scoring feature on this devices is not closing properly after patient's exams.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K042328 (Siemens Medical Systems, Inc., 2004) has gone furthest, with 30 descendants of its own.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

https://510kreport.com/device/K003014 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003014: Somatom Emotion MS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003014

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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