510(k) · Cleared

Cleared

Siemens SC9000/SC9015 Multigas and Multigas+ Modules

K965062510(k) TraditionalCleared Jun 4, 1997168-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 4, 1997 as substantially equivalent to K951127 (Hewlett-Packard GmbH, 1995) and 1 other predicate after a 168-day review. Its family tree reaches back 1 generation to 1995. 18 later devices descend from it.

Decided: Jun 4, 1997
Review: 168 days
Class: Class II
Product code: DSI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K951127 (1995). 2 ancestors in all. 18 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK951127 Hewlett-Packard Model M1026A Anesthetic Gas ModuleHewlett-Packard GmbH · 1995
This deviceK965062 Siemens SC9000/SC9015 Multigas and Multigas+ ModulesSiemens Medical Solutions USA, Inc. · 1997
Descendant · cites it directly · 17 of its ownK020046 Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002
Descendant · 2 generations on · 14 of its ownK030105 Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003
Descendant · 3 generations on · 11 of its ownK080342 Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008
Descendant · 4 generations on · 5 of its ownK082785 Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008
Descendant · 5 generations on · 4 of its ownK151080 Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · Recalled

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2002high 3 (2008) · low 0 (2004)2026

Most influential descendants

Showing 5 of 18 · See all

K020046Multigas Unit, Model AG-920RANihon Kohden America, Inc. · 2002 · cites it directly17descendants
K030105Anesthesia Monitor; Bedside Monitor, Series BSM-5130ANihon Kohden America, Inc. · 2003 · 2 generations on14descendants
K080342Nihon Kohden Bedside Monitor, Model BSM-6000S SeriesNihon Kohden America, Inc. · 2008 · 3 generations on11descendants
K082785Nihon Kohden Bedside Monitor, BSM 9100A SeriesNihon Kohden America, Inc. · 2008 · 4 generations on5descendants
K151080Nihon Kohden CSM 1901 Bedside MonitorNihon Kohden · 2015 · 5 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K951127	Hewlett-Packard Model M1026A Anesthetic Gas Module	Hewlett-Packard GmbH	1995	—
0 (this device)	K965062	Siemens SC9000/SC9015 Multigas and Multigas+ Modules	Siemens Medical Solutions USA, Inc.	1997	—
+1	K020046	Multigas Unit, Model AG-920RA	Nihon Kohden America, Inc.	2002	—
+2	K030105	Anesthesia Monitor; Bedside Monitor, Series BSM-5130A	Nihon Kohden America, Inc.	2003	—
+3	K080342	Nihon Kohden Bedside Monitor, Model BSM-6000S Series	Nihon Kohden America, Inc.	2008	—
+4	K082785	Nihon Kohden Bedside Monitor, BSM 9100A Series	Nihon Kohden America, Inc.	2008	—
+5	K151080	Nihon Kohden CSM 1901 Bedside Monitor	Nihon Kohden	2015	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2006	1	0
2008	3	0
2011	2	0
2015	1	0
2016	1	0
2017	2	0
2021	3	0
2022	2	0
2026	1	0

FIG. 1 — Lineage of K965062, 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? (2)

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
*	K951127	Hewlett-Packard Model M1026A Anesthetic Gas Module Summary page 2 …s modules use the same hardware, provided by the same OEM manufacturer, as the Hewlett-Packard model M1026A Anesthesia Gas Module Gas Module, cleared under 510(K) number K951127. The SC9000/9015 Bedside Monitor System (510 (K) number K946306) provides the display and user interface capabilities for the MU…	Hewlett-Packard GmbH	1995	—
*	K946306	Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System Summary page 2 …turer, as the Hewlett-Packard model M1026A Anesthesia Gas Module Gas Module, cleared under 510(K) number K951127. The SC9000/9015 Bedside Monitor System (510 (K) number K946306) provides the display and user interface capabilities for the MULTIGas ™ modules. 5. Device Description There are two multi gas…	Siemens Medical Solutions USA, Inc.	1995	—

Also cleared against K951127: 4 other devices →

What descends from it? (18)

See all 18

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K020046	Multigas Unit, Model AG-920RA	Nihon Kohden America, Inc.	2002	17

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?

None of the 2 ancestors has a recall.
Of its descendants, K020046 (Nihon Kohden America, Inc., 2002) has gone furthest, with 17 descendants of its own.
4 other devices also cite its predicate K951127.

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 Siemens SC9000/SC9015 MULTIGas ™ and MULTIGas+ ™ Modules are 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 these devices are required to-measure- - - - - any one or more of the following parameters: e Respiration rate inspired and expired Carbon Dioxide (CO,) inspired and expired Oxygen (MULTIGas+…

Read the full statement (110 words)

The Siemens SC9000/SC9015 MULTIGas ™ and MULTIGas+ ™ Modules are 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 these devices are required to-measure- - - - -

any one or more of the following parameters:

e Respiration rate

inspired and expired Carbon Dioxide (CO,)

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

MRI Compatibility Statement:

The Siemens SC9000/9015 MULTIGas tm and MULTIGas+ tm modules are not intended for use in an

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/K965062 · printed Nov 6, 2026

Cite this page

510(k) Report. “K965062: Siemens SC9000/SC9015 Multigas and Multigas+ Modules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K965062

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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