510(k) · Cleared

Cleared

Siemens SC 8000 Bedside Monitor with Advanced Communication Option

K990563510(k) SpecialCleared Mar 19, 199925-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 Mar 19, 1999 after a 25-day review. The FDA summary names no predicate by number. 293 later devices descend from it.

Decided: Mar 19, 1999
Review: 25 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 0

293 later devices descend from it, 7 citing it directly.

This deviceK990563 Siemens SC 8000 Bedside Monitor with Advanced Communication OptionSiemens Medical Solutions USA, Inc. · 1999
Descendant · cites it directly · 289 of its ownK022889 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC…Siemens Medical Solutions USA, Inc. · 2002
Descendant · 2 generations on · 280 of its ownK031340 Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC…Siemens Medical Solutions USA, Inc. · 2003
Descendant · 3 generations on · 251 of its ownK041956 Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004
Descendant · 4 generations on · 249 of its ownK050762 Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50…Philips Medizin Systeme Boeblingen GmbH · 2005
Descendant · 5 generations on · 247 of its ownK051106 The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90…Philips Medizin Systeme Boeblingen GmbH · 2005

Showing 5 of 293 descendants. See all descendants

Descendants cleared per year

2001high 21 (2023) · low 1 (2001)2026

Most influential descendants

Showing 5 of 293 · See all

K022889Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…Siemens Medical Solutions USA, Inc. · 2002 · cites it directly289descendants
K031340Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with ScioSiemens Medical Solutions USA, Inc. · 2003 · 2 generations on280descendants
K041956Emg - Essential Gas Module, Model M1013ADraeget Medical AG & Co. Kgaa · 2004 · 3 generations on251descendants
K050762Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70 and MP90Philips Medizin Systeme Boeblingen GmbH · 2005 · 4 generations on249descendants
K051106The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient MonitorsPhilips Medizin Systeme Boeblingen GmbH · 2005 · 5 generations on247descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K990563	Siemens SC 8000 Bedside Monitor with Advanced Communication Option	Siemens Medical Solutions USA, Inc.	1999	—
+1	K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL &…	Siemens Medical Solutions USA, Inc.	2002	—
+2	K031340	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with…	Siemens Medical Solutions USA, Inc.	2003	—
+3	K041956	Emg - Essential Gas Module, Model M1013A	Draeget Medical AG & Co. Kgaa	2004	—
+4	K050762	Philips Intellivue Patient Monitor, Models MP20, MP30, MP40, MP50, MP60, MP70…	Philips Medizin Systeme Boeblingen GmbH	2005	—
+5	K051106	The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue…	Philips Medizin Systeme Boeblingen GmbH	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	1	0
2003	4	0
2004	6	0
2005	9	0
2006	15	0
2007	7	0
2008	5	0
2009	6	0
2010	10	0
2011	11	0
2012	11	0
2013	13	0
2014	11	0
2015	11	0
2016	13	0
2017	13	0
2018	15	0
2019	11	0
2020	11	0
2021	14	0
2022	20	0
2023	21	0
2024	18	0
2025	21	0
2026	15	0

FIG. 1 — Lineage of K990563, 1999–2026Source: 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?

The FDA summary names no predicate by number.

What descends from it? (293)

See all 293

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

Number	Device	Applicant	Decided	Descendants
K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…	Siemens Medical Solutions USA, Inc.	2002	289
K033957	Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC…	Draeger Medical Systems, Inc.	2004	233
K033694	Infinity Modular Monitors VF4 Modifications	Draeger Medical Systems, Inc.	2004	37
K012016	Infinity SC 8000 with Advanced Communication Option II	Siemens Medical Solutions USA, Inc.	2001	29
K030738	Siemens Multiview Infinity Telemetry System	Siemens Medical Solutions USA, Inc.	2003	7
K052119	Teslaguard, Model Eft G04	Mammendorfer Institute For Physics & Medicine GmbH	2006	6
K031433	Siemens Infinity Modular Monitors, Models SC 7000, SC 9000XL and SC 8000 with VF3…	Siemens Medical Solutions USA, Inc.	2003	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?

Of its descendants, K022889 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 289 descendants of its own.

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?

The SC 8000 Bedside monitor with Advanced Communication Option is capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Pulse rate (central) apnea ST Segment Analysis 12-Lead ST Segment Analysis With the MultiGas™ and MultiGas+™ modules the SC8000 is capable of measuring: Respiration rate Inspired and expired Carbon Dioxide (CO2) Inspired and expired…

Read the full statement (225 words)

The SC 8000 Bedside monitor with Advanced Communication Option is capable of monitoring:

Heart rate

Respiration rate

Invasive pressure

Non-invasive pressure

Arrhythmia

Temperature

Cardiac output

Arterial oxygen saturation

Pulse rate

(central) apnea

ST Segment Analysis

12-Lead ST Segment Analysis

With the MultiGas™ and MultiGas+™ modules the SC8000 is capable of measuring:

Respiration rate

Inspired and expired Carbon Dioxide (CO2)

Inspired and expired Oxygen (MultiGas+™ only)

Average inspired Oxygen (MultiGas™ only)

Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, and Nitrous Oxide.

The SC 8000 Bedside Monitor can interface with third party devices.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.

The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

MRI Compatibility Statement:

The Siemens SC 8000 Bedside Monitor 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/K990563 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990563: Siemens SC 8000 Bedside Monitor with Advanced Communication Option.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990563

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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