510(k) · Cleared

Cleared

Siemens Multi View Infinity Telemetry System

K024108510(k) SpecialCleared Dec 18, 20025-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. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Dec 18, 2002 as substantially equivalent to K972714 (Siemens Medical Solutions USA, Inc., 1997) and 2 other predicates after a 5-day review. Its family tree reaches back 3 generations to 1995. 35 later devices descend from it.

Decided: Dec 18, 2002
Review: 5 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K951371 (1995). 4 ancestors in all. 35 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK951371 1481 T Digital Telemetry System with S-T Segment Analysis OptionSiemens Medical Solutions USA, Inc. · 1995
2 generations backK972714 Siemens Multiview Workstation Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 1997
1 generation backK983980 Siemens Multiview Infinity Telemetry System Enhancement, Additional…Siemens Medical Solutions USA, Inc. · 1998
This deviceK024108 Siemens Multi View Infinity Telemetry SystemSiemens Medical Solutions USA, Inc. · 2002
Descendant · cites it directly · 26 of its ownK061379 Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007
Descendant · 2 generations on · 25 of its ownK130711 Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · Recalled
Descendant · 3 generations on · 23 of its ownK151860 Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · Recalled
Descendant · 4 generations on · 19 of its ownK182543 Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap…Snap40, Ltd. · 2018
Descendant · 5 generations on · 18 of its ownK190073 Wearable Device, Home Package in Carry Case with Homehub, Home…Current Health, Ltd. · 2019

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2003high 6 (2024) · low 0 (2004)2026

Most influential descendants

Showing 5 of 35 · See all

K061379Infinity Telesmart Telemetry SystemDraeger Medical Systems, Inc. · 2007 · cites it directly26descendants
K130711Infinity Centralstation with Infinity M300Draeger Medical Systems, Inc. · 2013 · 2 generations on25descendants
K151860Infinity CentralStation WideDraeger Medical Systems, Inc. · 2015 · 3 generations on23descendants
K182543Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device…Snap40, Ltd. · 2018 · 4 generations on19descendants
K190073Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case…Current Health, Ltd. · 2019 · 5 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K951371	1481 T Digital Telemetry System with S-T Segment Analysis Option	Siemens Medical Solutions USA, Inc.	1995	—
−2	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	—
0 (this device)	K024108	Siemens Multi View Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2002	—
+1	K061379	Infinity Telesmart Telemetry System	Draeger Medical Systems, Inc.	2007	—
+2	K130711	Infinity Centralstation with Infinity M300	Draeger Medical Systems, Inc.	2013	2
+3	K151860	Infinity CentralStation Wide	Draeger Medical Systems, Inc.	2015	2
+4	K182543	Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple…	Snap40, Ltd.	2018	—
+5	K190073	Wearable Device, Home Package in Carry Case with Homehub, Home Package in…	Current Health, Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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 K024108, 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 MHX? 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 MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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? (3)

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
*	K972714	Siemens Multiview Workstation Infinity Telemetry System Summary page 1 …21 CFR 870.2700 Radiofrequency physiological signal transmitter and 74DRG I1 21 CFR 870.2910 Legally Marketed Device Identification: K9727 14 INFINITY MultiView Workstation Telemetry Enhancement K983980 INFINITY MultiView Workstation Telemetry Modifications KO03 17…	Siemens Medical Solutions USA, Inc.	1997	—
*	K983980	Siemens Multiview Infinity Telemetry System Enhancement, Additional Arrhythmia Calls Summary page 1 …er and 74DRG I1 21 CFR 870.2910 Legally Marketed Device Identification: K9727 14 INFINITY MultiView Workstation Telemetry Enhancement K983980 INFINITY MultiView Workstation Telemetry Modifications KO03 179 INFINITY Telemetry System Modifications Other Relevant Submis…	Siemens Medical Solutions USA, Inc.	1998	—
*	K003179	Siemens Multiview Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2000	—

Also cleared against K972714: 1 other device →

What descends from it? (35)

See all 35

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

Number	Device	Applicant	Decided	Descendants
K061379	Infinity Telesmart Telemetry System	Draeger Medical Systems, Inc.	2007	26
K030738	Siemens Multiview Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2003	7

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?

The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K061379 (Draeger Medical Systems, Inc., 2007) has gone furthest, with 26 descendants of its own.
1 other device also cites its predicate K972714.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

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

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

What is it indicated for?

Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) 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

Arterial oxygen saturation

Pulse rate

ST segment analysis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024108 · printed Nov 3, 2026

Cite this page

510(k) Report. “K024108: Siemens Multi View Infinity Telemetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024108

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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