# K033694: Infinity Modular Monitors VF4 Modifications

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Mar 22, 2004 after 119 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: 5 generations back to K946306 (1995). 21 ancestors in all.
37 later devices descend from it; 1 cites it directly.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983632: Siemens SC 8000 Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K990563: Siemens SC 8000 Bedside Monitor with Advanced Communication Option, Siemens Medical Solutions USA, Inc. (1999) Summary page 1.
- K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio, Siemens Medical Solutions USA, Inc. (2003). Cleared while this submission was under review Summary page 1.
- K003243: Siemens Infinity Modular Monitors Model SC 8000; SC 7000; SC 9000XL, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K982730: SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K980882: Siemens  SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

## Most influential descendants
- K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL (2005), 36 descendants of its own
- K051658: Infinity Alpha (2005), 32 descendants of its own
- K060039: Infinity Delta and Kappa Series Monitors with VF6 Modifications (2006), 27 descendants of its own
- K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL (2007), 26 descendants of its own
- K061379: Infinity Telesmart Telemetry System (2007), 26 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 and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. With etCO2 the monitors can 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; and 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/K033694
Methodology: https://510kreport.com/methodology