# K041087: Infinity Gamma

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: May 12, 2004 after 16 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 K844187 (1985). 11 ancestors in all.
36 later devices descend from it; 2 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033600: Infinity Gammaxl, Draeger Medical Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K042656: Infinity Gamma/Gammaxl and Vista with VF5 (2004), 35 descendants of its own
- K053484: Infinity Gamma / Gammaxl, Infinity Vista (2006), 34 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
- K093788: Infinity Acute Care System (Iacs) Monitoring Solution (2010), 24 descendants of its own

## Indications for use
This device is capable of monitoring: * Heart Rate · Respiration Rate * Invasive Pressure · Non-Invasive Pressure * Arrhythmia · Temperature * Arterial oxygen saturation * Pulse rate * central apnea (accomplished through impedance plethysmography) * apnea (accomplished through capnograpy) * end-tidal C02 · ST Segment Analysis This Infinity Gamma will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network. The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population. MRI Compatibility Statement: The INFINITY Gamma is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K041087
Methodology: https://510kreport.com/methodology