# K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Apr 14, 2004 after 77 days
- Product code: NHP (Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration))
- Device class: 2
- Regulation: 21 CFR 868.1500
- 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). 29 ancestors in all.
241 later devices descend from it; 4 cite it directly.
0 of 271 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 1.
- K030313: Siemens Infinity SC 6002XL Modifications, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K993974: Siemens Infinity SC 6002XL Portable Patient Monitor, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K031340: Siemens Infinity Modular Monitors, Models SC 8000, SC 7000 and SC 9000XL, with Scio, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.

## Most influential descendants
- K051628: Infinity Monitors with Scio Modifications (2005), 230 descendants of its own
- K053204: Intellivue Gas Modules, Models G5 M1019A and G1 M1013A (2006), 222 descendants of its own
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), 221 descendants of its own
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), 211 descendants of its own
- K062283: The Philips MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90 Intellivue Patient Monitors (2006), 188 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 GammaXL and SC 6802XL 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. When 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 Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors. 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 GammaXL and SC 6802XL are not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K040188
Methodology: https://510kreport.com/methodology