# K051628: Infinity Monitors with Scio Modifications

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Jul 20, 2005 after 30 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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: 6 generations back to K946306 (1995). 34 ancestors in all.
230 later devices descend from it; 2 cite it directly.
0 of 265 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K033957: Infinity Modular Monitors VF4 Modifications with Scio, Models Delta, Delta XL, Kappa, SC 8000, SC 7000, SC 9000XL, Draeger Medical Systems, Inc. (2004) Summary page 1.
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module, Draeger Medical Systems, Inc. (2004) Summary page 1.
- K040847: Modification to Vamos Anesthetic Gas Monitor, Draeger Medical, Inc. (2004) Summary page 1.

## Most influential descendants
- K053204: Intellivue Gas Modules, Models G5 M1019A and G1 M1013A (2006), 222 descendants of its own
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), 221 descendants of its own
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), 211 descendants of its own
- K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors (2006), 188 descendants of its own
- K062392: Philips MP5 Intellivue Patient Monitor (2006), 176 descendants of its own

## Indications for use
The INFINITY Modular monitors are capable of monitoring: * Heart rate * Respiration rate * Invasive pressure * Non-invasive pressure * Arrhythmia * Temperature * Cardiac output * Arterial oxygen saturation • Pulse rate * Apnea * ST Segment Analysis * 12-Lead ST Segment Analysis * tcpO2/tcpCO2 * EEG signals * FiO2 The Scio module samples breathing gases from adults and pediatrics. The gas modules continuously measure the content of C02, N20, 02 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desfiurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. With etCO2 the monitors gar measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2±Respiratory Mechanics, Spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter. The devices are 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 devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; anti tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia. MRI Compatibility Statement: The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K051628
Methodology: https://510kreport.com/methodology