# K070566: Infinity Delta/Delta XL/ Kappa/ Gamma X XL/ Vista XL/ SC7000/SC8000/ SC9000XL

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Jun 4, 2007 after 96 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K923682 (1992). 57 ancestors in all.
26 later devices descend from it; 2 cite it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060039: Infinity Delta and Kappa Series Monitors with VF6 Modifications, Draeger Medical Systems, Inc. (2006) Summary page 1.
- K051628: Infinity Monitors with Scio Modifications, Draeger Medical Systems, Inc. (2005) Summary page 1.
- K043439: Infinity Modular Monitors with VF5 Modifications (Delta/Kappa/Delta XL/Vista XL/Gamma X XL and SC 7000/8000/9000XL, Draeger Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution (2010), 24 descendants of its own
- K113798: Infinity Acute Care System, Infinity Mcable- Masimo Rainbow Set (2012), 23 descendants of its own
- K182543: Wearable Device ; Cradle ; Small Strap, Medium Strap, Large Strap ; Multiple Device Charger ; Hospital Starter Package (2018), 19 descendants of its own
- K190073: Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub (2019), 18 descendants of its own
- K191272: Wearable Device, Wearable Package (2019), 16 descendants of its own

## Recalls of this device
- Oct 31, 2011 · Not classified · Z-0281-2012: Firm received 2 complaints reporting Ventricular Fibrillation (Vfib) arrhythmias were not recognized by the monitor and did not alarm when the Masimo SET pod is used for SpO2 measurements.
- Jul 29, 2011 · Not classified · Z-3047-2011: Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
- Jul 29, 2011 · Not classified · Z-3048-2011: Monitor keys may spontaneously become inoperative or active. This may cause a membrane switch panel malfunction, which could result in the monitor discharging a patient automatically.
- Jun 4, 2010 · Not classified · Z-2283-2010: Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
- Jun 4, 2010 · Not classified · Z-2284-2010: Monitor keys may become inoperative or activate spontaneously, causing a membrane switch panel malfunction. This may discharge a patient automatically.
- Nov 9, 2009 · Not classified · Z-0582-2010: monitor is rebooting/resetting

## 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 Scio gas module samples breathing gases from adults and pediatrics. The gas module continuously measure the content of C02, N20, 02 and one of the anes- thetic 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 pro- vided 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 parameterCardiac Output, ST Segment Analysis, and arrhythmiawhich are intendedfor use in the adult andpediatricpopulations only; and tcpO2 which is to be used in the neonatalpopulation 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/K070566
Methodology: https://510kreport.com/methodology