# K141756: Infinity Explorer Software, C700 for IT Patient Vicinity Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Draeger Medical Systems, Inc.
- Decided: Dec 12, 2014 after 165 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K060254 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060254: Modification to Infinity Explorer, Draeger Medical Systems, Inc. (2006) Summary page 4.

## Recalls of this device
- Feb 8, 2019 · Class II · Z-0975-2019: The firm is recalling their Delta family of patient monitors software due to cybersecurity vulnerabilities, which may cause the device to reboot, lose functionality, and/or lose communication.

## Indications for use
Infinity Explorer software enables the Patient Vicinity Workstation (PVW) to function as the secondary display for physiological parameters received from the primary Infinity modular monitors. Infinity Explorer displays only visual parameter alarm data for the connected modular monitor and does not generate audible alarms. Audible and visual alarms are available at the primary Infinity modular monitors. The device is intended to be used in an environment where patient care is provided by healthcare professionals such as 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 adult, pediatric, and neonatal populations. MRI Compatibility Statement: The Infinity Explorer is not compatible for use in a MRI magnetic field. Contraindications: There are no known contraindications.

Source page: https://510kreport.com/device/K141756
Methodology: https://510kreport.com/methodology