# K020144: Siemens Infinity SC 6002XL Modifications

- Pathway: 510(k) (Special)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 15, 2002 after 30 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K844187 (1985). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993974: Siemens Infinity SC 6002XL Portable Patient Monitor, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K002105: Siemens Infinity SC 6002XL Enhanced with ST Segment Analysis, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.

## 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 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 to be used 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 is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K020144
Methodology: https://510kreport.com/methodology