# K030313: Siemens Infinity SC 6002XL Modifications

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 11, 2003 after 12 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
No predicates in its family tree.
245 later devices descend from it; 3 cite it directly.
0 of 246 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033600: Infinity Gammaxl (2003), 244 descendants of its own
- K040188: Infinity Gammaxl and SC 6802XL with the Scio Gas Module (2004), 241 descendants of its own
- 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

## 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 end-tidal C O 2 ST Segment Analysis This device 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 Siemens 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 Siemens INFINITY SC 6002XL / SC 6802XL are not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K030313
Methodology: https://510kreport.com/methodology