510(k) · Cleared

Cleared

Siemens Infinity SC 6002XL Portable Patient Monitor

K993974510(k) TraditionalCleared Feb 22, 200090-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 Feb 22, 2000 as substantially equivalent to K980882 (Siemens Medical Solutions USA, Inc., 1998) and 4 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1985. 246 later devices descend from it.

Decided: Feb 22, 2000
Review: 90 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 5

Its longest line of descent runs back 3 generations to K844187 (1985). 8 ancestors in all. 246 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
2 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
1 generation backK962404 Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
This deviceK993974 Siemens Infinity SC 6002XL Portable Patient MonitorSiemens Medical Solutions USA, Inc. · 2000
Descendant · cites it directly · 244 of its ownK033600 Infinity GammaxlDraeger Medical Systems, Inc. · 2003
Descendant · cites it directly · 241 of its ownK040188 Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004
Descendant · 2 generations on · 230 of its ownK051628 Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005
Descendant · 3 generations on · 222 of its ownK053204 Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006
Descendant · 4 generations on · 221 of its ownK060541 The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue…Philips Medizin Systeme Boblingen GmbH · 2006 · Recalled

Showing 5 of 246 descendants. See all descendants

Descendants cleared per year

2002high 21 (2023) · low 1 (2002)2026

Most influential descendants

Showing 5 of 246 · See all

K033600Infinity GammaxlDraeger Medical Systems, Inc. · 2003 · cites it directly244descendants
K040188Infinity Gammaxl and SC 6802XL with the Scio Gas ModuleDraeger Medical Systems, Inc. · 2004 · cites it directly241descendants
K051628Infinity Monitors with Scio ModificationsDraeger Medical Systems, Inc. · 2005 · 2 generations on230descendants
K053204Intellivue Gas Modules, Models G5 M1019A and G1 M1013ADraeger Medical AG & Co. Kgaa · 2006 · 3 generations on222descendants
K060541The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsPhilips Medizin Systeme Boblingen GmbH · 2006 · 4 generations on221descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K844187	Siemens Sirecust 404N Neonatal Monitor	Siemens Medical Solutions USA, Inc.	1985	—
−2	K952054	Siemens Sirecust Monitoring (1200, 1200 Neo, 960)	Siemens Medical Solutions USA, Inc.	1996	—
−1	K962404	Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	1997	—
0 (this device)	K993974	Siemens Infinity SC 6002XL Portable Patient Monitor	Siemens Medical Solutions USA, Inc.	2000	—
+1	K033600	Infinity Gammaxl	Draeger Medical Systems, Inc.	2003	—
+1	K040188	Infinity Gammaxl and SC 6802XL with the Scio Gas Module	Draeger Medical Systems, Inc.	2004	—
+2	K051628	Infinity Monitors with Scio Modifications	Draeger Medical Systems, Inc.	2005	—
+3	K053204	Intellivue Gas Modules, Models G5 M1019A and G1 M1013A	Draeger Medical AG & Co. Kgaa	2006	—
+4	K060541	The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient…	Philips Medizin Systeme Boblingen GmbH	2006	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1996	1	0
1998	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	3	0
2005	1	0
2006	10	0
2007	5	0
2008	4	0
2009	5	0
2010	6	0
2011	9	0
2012	10	0
2013	11	0
2014	9	0
2015	9	0
2016	10	0
2017	12	0
2018	13	0
2019	10	0
2020	9	0
2021	14	0
2022	19	0
2023	21	0
2024	18	0
2025	21	0
2026	15	0

FIG. 1 — Lineage of K993974, 1985–2026Source: 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? (5)

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
*	K980882	Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor Summary page 1 …tor & Alarm System 74DSI 14 21 CFR 870.1025 Monitor, Physiological, Patient (with arrhythmia MHX I 21 CFR 870.1025 detection or alarms) Predicate Device Identification: K980882 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K982730 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K944350 SC 60…	Siemens Medical Solutions USA, Inc.	1998	—
*	K982730	SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor Summary page 1 …ical, Patient (with arrhythmia MHX I 21 CFR 870.1025 detection or alarms) Predicate Device Identification: K980882 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K982730 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K944350 SC 6000 / SC 6000P K962404 SC 6000 / SC 6000P Neonatal K955743 SC…	Siemens Medical Solutions USA, Inc.	1998	—
*	K944350	SC 6000/ SC 6000P/ R50 Summary page 1 …or alarms) Predicate Device Identification: K980882 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K982730 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K944350 SC 6000 / SC 6000P K962404 SC 6000 / SC 6000P Neonatal K955743 SC 6000 / SC 6000P w/Arrhythmia Other relevant submissions K98…	Siemens Medical Solutions USA, Inc.	1995	—
*	K962404	Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System Summary page 1 …Identification: K980882 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K982730 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K944350 SC 6000 / SC 6000P K962404 SC 6000 / SC 6000P Neonatal K955743 SC 6000 / SC 6000P w/Arrhythmia Other relevant submissions K983980 MV WS INFINITY Telemetr…	Siemens Medical Solutions USA, Inc.	1997	—
*	K955743	Siemens SC 6000/SC 6000 P Portable Bedside Monitoring System Summary page 1 …C 9000XL INFINITY Modular Bedside Monitor K982730 SC 7000 / SC 9000XL INFINITY Modular Bedside Monitor K944350 SC 6000 / SC 6000P K962404 SC 6000 / SC 6000P Neonatal K955743 SC 6000 / SC 6000P w/Arrhythmia Other relevant submissions K983980 MV WS INFINITY Telemetry System Additional Arrhythmia Calls…	Siemens Medical Solutions USA, Inc.	1996	—

Also cleared against K980882: 6 other devices →

What descends from it? (246)

See all 246

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

Number	Device	Applicant	Decided	Descendants
K033600	Infinity Gammaxl	Draeger Medical Systems, Inc.	2003	244
K040188	Infinity Gammaxl and SC 6802XL with the Scio Gas Module	Draeger Medical Systems, Inc.	2004	241
K020144	Siemens Infinity SC 6002XL Modifications	Siemens Medical Solutions USA, Inc.	2002	0

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 15 years and passes through 1 company; a new generation was cleared every 3.1 years on median.
None of the 8 ancestors has a recall.
Of its descendants, K033600 (Draeger Medical Systems, Inc., 2003) has gone furthest, with 244 descendants of its own.
6 other devices also cite its predicate K980882.

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?

This device is capable of monitoring: • Heart Rate • Respiration Rate • Invasive Pressure • Non-Invasive Pressure • Arrhythmia • Temperature • Arterial oxygen saturation • Pulse rate • (central) apnea • end-tidal CO2 The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is…

Read the full statement (129 words)

This device is capable of monitoring:

• Heart Rate

• Respiration Rate

• Invasive Pressure

• Non-Invasive Pressure

• Arrhythmia

• Temperature

• Arterial oxygen saturation

• Pulse rate

• (central) apnea

• end-tidal CO2

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia which is not intended for the neonatal population.

MRI Compatibility Statement:

The Siemens INFINITY SC 6002XL 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/K993974 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993974: Siemens Infinity SC 6002XL Portable Patient Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993974

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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