# K990068: Solar 9500 Information Monitor

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Jul 14, 1999 after 187 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: 2 generations back to K900598 (1990). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954852: Solar 9000 Anesthesia Information Monitor, Marquette Electronics, Inc. (1996) Summary page 1.
- K921669: Marquette SL Series Transport Remote Acquisition, Marquette Electronics, Inc. (1993) Summary page 1.

## Most influential descendants
- K030575: Modification to Solar 9500 Information Monitor (2003), 1 descendant of its own
- K033964: Solar 9500 Information Monitor (2004), 0 descendants of its own

## 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 meonitor physiologic parameter data oh adult, pediatric and neonatal patients, in high acuity areas such as operating room (OR), post anesthesia recovery (PARRY), 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 monitoring parameters are contained in Appendix B under Technical Specifications. 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.

Source page: https://510kreport.com/device/K990068
Methodology: https://510kreport.com/methodology