510(k) · Cleared

Cleared

Siemens Multiview Infinity Telemetry System

K003179510(k) SpecialCleared Nov 9, 200029-day reviewClass II21 CFR 870.1025

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. · DSI Detector And Alarm, Arrhythmia

Cleared on Nov 9, 2000 after a 29-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 36 later devices descend from it.

Decided: Nov 9, 2000
Review: 29 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 0

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

This deviceK003179 Siemens Multiview Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2000
Descendant · cites it directly · 35 of its ownK024108 Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002
Descendant · 2 generations on · 26 of its ownK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
Descendant · 3 generations on · 25 of its ownK130711 Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · Recalled
Descendant · 4 generations on · 23 of its ownK151860 Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · Recalled
Descendant · 5 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2002high 6 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 36 · See all

K024108Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002 · cites it directly35descendants
K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007 · 2 generations on26descendants
K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · 3 generations on25descendants
K151860Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · 4 generations on23descendants
K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 5 generations on19descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003179	Siemens Multiview Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2000	—
+1	K024108	Siemens Multi View Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2002	—
+2	K061379	Infinity Telesmart Telemetry System	Draeger Medical Systems, Inc.	2007	—
+3	K130711	Infinity Centralstation with Infinity M300	Draeger Medical Systems, Inc.	2013	2
+4	K151860	Infinity CentralStation Wide	Draeger Medical Systems, Inc.	2015	2
+5	K182543	Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple…	Snap40, Ltd.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	2	0
2006	1	0
2007	1	0
2010	1	0
2013	1	0
2015	3	0
2016	2	0
2018	1	0
2019	2	0
2020	3	0
2021	1	0
2022	2	0
2023	4	0
2024	6	0
2025	3	0
2026	2	0

FIG. 1 — Lineage of K003179, 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 DSI? 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 DSI device

#1 K243349 BodyGuardian Remote Monitoring System (BGRMS…score 13.1 · 9 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? (36)

See all 36

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

Number	Device	Applicant	Decided	Descendants
K024108	Siemens Multi View Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2002	35

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, K024108 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 35 descendants of its own.

How does its category compare?

All DSI devices

DSI Detector And Alarm, Arrhythmia: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DSI

1in 2025

2007high 9 (2015) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DSI

243in 2019

2007high 243 (2019) · low 70 (2008)2026

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

Recalls per year · DSI

18in 2025

2007high 18 (2025) · low 0 (2013)2026

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

Adverse event reports per year · DSI

712in 2025

2007high 4,352 (2016) · low 64 (2007)2025

MAUDE reports naming product code DSI, 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	7	151	4	64
2008	5	70	8	156
2009	6	73	3	279
2010	6	111	5	823
2011	6	114	3	793
2012	3	113	1	766
2013	1	—	0	795
2014	4	200	0	1,000
2015	9	127	0	1,645
2016	6	224	0	4,352
2017	0	—	0	3,594
2018	2	—	1	3,648
2019	3	243	4	3,485
2020	2	—	2	3,084
2021	0	—	0	3,092
2022	0	—	1	1,638
2023	2	—	2	1,616
2024	1	—	0	1,320
2025	1	—	18	712
2026	1	—	1	—

https://510kreport.com/device/K003179 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003179: Siemens Multiview Infinity Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003179

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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