# K993974: Siemens Infinity SC 6002XL Portable Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 22, 2000 after 90 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: 3 generations back to K844187 (1985). 8 ancestors in all.
246 later devices descend from it; 3 cite it directly.
0 of 255 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980882: Siemens  SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K982730: SC 7000 & SC 9000 XL Infinity Modular Bedside Monitor, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.
- K944350: SC 6000/ SC 6000P/ R50, Siemens Medical Solutions USA, Inc. (1995) Summary page 1.
- K962404: Siemens SC 6000 & SC 6000 P Portable Bedside Monitoring System, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K955743: Siemens SC 6000/SC 6000 P Portable Bedside Monitoring System, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.

## 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 CO2 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 to be used on Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia which is not intended for the neonatal population. MRI Compatibility Statement: The Siemens INFINITY SC 6002XL is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K993974
Methodology: https://510kreport.com/methodology