# K042904: Infinity Kappa XLT

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Feb 18, 2005 after 120 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). 26 ancestors in all.
28 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040945: Modification to Infinity Explorer, Draeger Medical Systems, Inc. (2004) 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.
- K012016: Infinity SC 8000 with Advanced Communication Option II, Siemens Medical Solutions USA, Inc. (2001)

## Most influential descendants
- 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
- 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

## Indications for use
The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST Segment Analysis, and 12-Lead ST Segment Analysis. The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system. Kappa XLT receives EEG signals when connected to an Infinity EEG pod. The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device. The SCIO module sample breathing gases from adults and pediatrics. The gas module continuously measures the content of C02, N20, 02 and one of the anesthetic agents, halothane, isollurane., Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to Kappa XLT. With etCO2 the Kappa XLT 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 device can interface with specific third party devices via an RS 232 connection. The device is 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. MRI Compatibility Statement: The Infinity Kappa XLT is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K042904
Methodology: https://510kreport.com/methodology