# K040945: Modification to Infinity Explorer

- Pathway: 510(k) (Special)
- Applicant: Draeger Medical Systems, Inc.
- Decided: May 12, 2004 after 30 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- 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 K900598 (1990). 10 ancestors in all.
30 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030615: Infinity Explorer, Siemens Medical Solutions USA, Inc. (2003) Summary page 1.
- K013515: Infinity Explorer, Siemens Medical Solutions USA, Inc. (2002) Summary page 1.

## Most influential descendants
- K042904: Infinity Kappa XLT (2005), 28 descendants of its own
- 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

## Indications for use
This device is capable of displaying physiological parameters received from INFINITY Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system. 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 device is intended for use with the adult, pediatric and neonatal populations. The INFINITY EXPLORER is not compatible for use in a MRI magnetic field.

Source page: https://510kreport.com/device/K040945
Methodology: https://510kreport.com/methodology