# K053484: Infinity Gamma / Gammaxl, Infinity Vista

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Feb 22, 2006 after 69 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K946306 (1995). 32 ancestors in all.
34 later devices descend from it; 2 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042656: Infinity Gamma/Gammaxl and Vista with VF5, Draeger Medical Systems, Inc. (2004) Summary page 1.
- K033600: Infinity Gammaxl, Draeger Medical Systems, Inc. (2003) Summary page 1.
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module, Draeger Medical Systems, Inc. (2004) Summary page 1.
- K041087: Infinity Gamma, Draeger Medical Systems, Inc. (2004) Summary page 1.

## 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

## Recalls of this device
- Nov 17, 2006 · Not classified · Z-0302-2007: Top cover of assembly may separate. The situation can result in the monitor falling, which could result in an injury to the clinician or patient.

## Indications for use
This devices are capable of monitoring: * Heart Rate * Respiration Rate * Invasive Pressure * Non-Invasive Pressure * Arrhythmia * Temperature * Arterial oxygen saturation * Pulse rate * central apnea * end-tidal C02* * ST Segment Analysis This device will produce visual and audible alarms it any of these parameters vary beyond preset limits and produce timned or alarm recordings. The devices will connect to R50 recorders either directly or via the Infinity network. When a GammaXL is connected to a SCIO* module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of C02, N20, 02 and one of the anesthetic agents, Halothane, Isoflurane, Enflurane, Sevoflurane and Desfiurane in any mixture and communi cates real time and derived gas information to the GammaXL. The device is intended to be used in an 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 Arhivthmina and ST Scment Anah'sis which are not intcinded for the neonatal population. * not available with Infinity Vista

Source page: https://510kreport.com/device/K053484
Methodology: https://510kreport.com/methodology