510(k) · Cleared

Cleared

Siemens Multiview Workstation Infinity Telemetry System

K972714510(k) TraditionalCleared Oct 17, 199788-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 Oct 17, 1997 as substantially equivalent to K951371 (Siemens Medical Solutions USA, Inc., 1995) after an 88-day review. Its family tree reaches back 1 generation to 1995. 37 later devices descend from it.

Decided: Oct 17, 1997
Review: 88 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K951371 (1995). 37 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK951371 1481 T Digital Telemetry System with S-T Segment Analysis OptionSiemens Medical Solutions USA, Inc. · 1995
This deviceK972714 Siemens Multiview Workstation Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 1997
Descendant · cites it directly · 36 of its ownK983980 Siemens Multiview Infinity Telemetry System Enhancement, Additional…Siemens Medical Solutions USA, Inc. · 1998
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

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1998high 6 (2024) · low 0 (1999)2026

Most influential descendants

Showing 5 of 37 · See all

K983980Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia CallsSiemens Medical Solutions USA, Inc. · 1998 · cites it directly36descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951371	1481 T Digital Telemetry System with S-T Segment Analysis Option	Siemens Medical Solutions USA, Inc.	1995	—
0 (this device)	K972714	Siemens Multiview Workstation Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	1997	—
+1	K983980	Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia…	Siemens Medical Solutions USA, Inc.	1998	—
+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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0
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 K972714, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K951371	1481 T Digital Telemetry System with S-T Segment Analysis Option Summary page 1 …ent monitor w/alarm 74MLD 1 21 CFR 870.1025 4. Predicate Device Information Siemens 1481 T Digital Telemetry system granted premarket clearance under 510(k) file number K951371. 5. Device Description The Siemens MultiView Workstation consists of a PC workstation, up to two CRT displays, keyboard, mouse/…	Siemens Medical Solutions USA, Inc.	1995	—

Also cleared against K951371: 2 other devices →

What descends from it? (37)

See all 37

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

Number	Device	Applicant	Decided	Descendants
K983980	Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia Calls	Siemens Medical Solutions USA, Inc.	1998	36
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?

Its one ancestor has no recall.
Of its descendants, K983980 (Siemens Medical Solutions USA, Inc., 1998) has gone furthest, with 36 descendants of its own.
2 other devices also cite its predicate K951371.

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	—

What is it indicated for?

Use of the MultiView (SC3000) Workstation Infinity Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physician, Nurse, Technician) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:

Heart rate

ECG arrhythmia analysis

ECG ST segment elevation or depression

Pulse rate

Arterial oxygen saturation.

MRI Compatibility Statement:

The MultiView (SC3000) Workstation Infinity Telemetry System is not compatible for use in a MRI magnetic field.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K972714 · printed Nov 6, 2026

Cite this page

510(k) Report. “K972714: Siemens Multiview Workstation 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/K972714

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026