510(k) · Cleared

Cleared

Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor

K980882510(k) TraditionalCleared Jun 5, 199888-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 Jun 5, 1998 as substantially equivalent to K946306 (Siemens Medical Solutions USA, Inc., 1995) after an 88-day review. Its family tree reaches back 1 generation to 1995. 309 later devices descend from it.

Decided: Jun 5, 1998
Review: 88 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K946306 (1995). 309 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK946306 Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring SystemSiemens Medical Solutions USA, Inc. · 1995
This deviceK980882 Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside MonitorSiemens Medical Solutions USA, Inc. · 1998
Descendant · cites it directly · 292 of its ownK012770 Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002
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

Showing 5 of 309 descendants. See all descendants

Descendants cleared per year

2000high 23 (2023) · low 0 (2001)2026

Most influential descendants

Showing 5 of 309 · See all

K012770Infinity MICRO2+Siemens Medical Solutions USA, Inc. · 2002 · cites it directly292descendants
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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K946306	Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System	Siemens Medical Solutions USA, Inc.	1995	—
0 (this device)	K980882	Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor	Siemens Medical Solutions USA, Inc.	1998	—
+1	K012770	Infinity MICRO2+	Siemens Medical Solutions USA, Inc.	2002	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	4	0
2003	7	0
2004	7	0
2005	9	0
2006	15	0
2007	7	0
2008	5	0
2009	6	0
2010	11	0
2011	11	0
2012	11	0
2013	15	0
2014	11	0
2015	12	0
2016	13	0
2017	14	0
2018	16	0
2019	11	0
2020	11	0
2021	14	0
2022	20	0
2023	23	0
2024	18	0
2025	22	0
2026	15	0

FIG. 1 — Lineage of K980882, 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
*	K946306	Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System Summary page 1 …30 End-tidal Carbon-Dioxide Monitor 73CCK I 21 CFR 868.1400 Predicate Device Identification: Siemens SC9000/SC9015 Patient Monitoring System, original 510(k) submission K946306. 1 COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Electronics Avenuce Tel: (978) 907-…	Siemens Medical Solutions USA, Inc.	1995	—

Also cleared against K946306: 8 other devices →

What descends from it? (309)

See all 309

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

Number	Device	Applicant	Decided	Descendants
K012770	Infinity MICRO2+	Siemens Medical Solutions USA, Inc.	2002	292
K022889	Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 & SC 9000XL & Siemens…	Siemens Medical Solutions USA, Inc.	2002	289
K993974	Siemens Infinity SC 6002XL Portable Patient Monitor	Siemens Medical Solutions USA, Inc.	2000	246
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
K020440	Newcor	Siemens Medical Systems, Inc.	2002	9
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?

Its one ancestor has no recall.
Of its descendants, K012770 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 292 descendants of its own.
8 other devices also cite its predicate K946306.

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?

The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring: Heart rate Respiration rate Invasive pressure Non-invasive pressure Arrhythmia Temperature Cardiac output Arterial oxygen saturation Puise rate End-tidal carbon dioxide (central) apnea ST segment analysis With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring: Respiration rate {nspired and expired Carbon Dioxide (CO2) Inspired and…

Read the full statement (214 words)

The SC 7000 and SC 9000XL INFINITY Modular Bedside monitors are capable of monitoring:

Heart rate

Respiration rate

Invasive pressure

Non-invasive pressure

Arrhythmia

Temperature

Cardiac output

Arterial oxygen saturation

Puise rate

End-tidal carbon dioxide

(central) apnea

ST segment analysis

With the MultiGas™ and MultiGas+™ modules the SC 7000 and SC 9000XL are capable of measuring:

Respiration rate

{nspired and expired Carbon Dioxide (CO2)

Inspired and expired Oxygen (MultiGas+™ only)

Average inspired Oxygea (MultiGas™ only)

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

and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

The devices are intended to be used in the environment where patient care is provided-by-Healthcare Professionals, i.c. 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 devices are 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; and Arrhythmia which is intended for use in the adult population only.

MRI Compatibility Statement:

The Siemens SC 7000 and SC 9000XL INFINITY Modular Bedside Monitors are not compatible for use in a MR1 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/K980882 · printed Nov 4, 2026

Cite this page

510(k) Report. “K980882: Siemens SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980882

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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