# K033964: Solar 9500 Information Monitor

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jan 15, 2004 after 24 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- 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: 4 generations back to K900598 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030575: Modification to Solar 9500 Information Monitor, Ge Medical Systems Information Technologies (2003) Summary page 1.

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0524-2019: The patient monitors may simultaneously restart as designed if all are connected to the same network and a network overload occurs for a prolonged time.

## Indications for use
The Solar® 9500 Information Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. Physiologic data includes electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, oxygen, anesthetic gas concentrations and mixed venous oxygen saturation, as summarized in the Solar® 9500 Operator's Manual. The Solar® 9500 Information Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital INTRAnet data via a Web Browser at the point-of-care. This information can be displayed, trended, stored, and printed.

Source page: https://510kreport.com/device/K033964
Methodology: https://510kreport.com/methodology