# K965062: Siemens SC9000/SC9015 Multigas and Multigas+ Modules

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Jun 4, 1997 after 168 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951127 (1995). 2 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951127: Hewlett-Packard Model M1026A Anesthetic Gas Module, Hewlett-Packard GmbH (1995) Summary page 2.
- K946306: Siemens SC 9000 Bedside Monitor, SC 9015 Bedside Mointoring System, Siemens Medical Solutions USA, Inc. (1995) Summary page 2.

## Most influential descendants
- K020046: Multigas Unit, Model AG-920RA (2002), 17 descendants of its own
- K030105: Anesthesia Monitor; Bedside Monitor, Series BSM-5130A (2003), 14 descendants of its own
- K080342: Nihon Kohden Bedside Monitor, Model BSM-6000S Series (2008), 11 descendants of its own
- K082785: Nihon Kohden Bedside Monitor, BSM 9100A Series (2008), 5 descendants of its own
- K151080: Nihon Kohden CSM 1901 Bedside Monitor (2015), 4 descendants of its own

## Indications for use
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

Source page: https://510kreport.com/device/K965062
Methodology: https://510kreport.com/methodology