# K954852: Solar 9000 Anesthesia Information Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Marquette Electronics, Inc.
- Decided: May 29, 1996 after 219 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K900598 (1990). 1 ancestor in all.
4 later devices descend from it; 2 cite 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)
- K900598: Tramscope System, Marquette Electronics, Inc. (1990). Our OCR of the scanned summary read K900588, FDA’s number for Acu-Band Accupressure Wrist Band (Euro-Am Pharma, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Tramscope System”.

## Most influential descendants
- K990068: Solar 9500 Information Monitor (1999), 2 descendants of its own
- K030575: Modification to Solar 9500 Information Monitor (2003), 1 descendant of its own
- K033964: Solar 9500 Information Monitor (2004), 0 descendants of its own
- K980756: Corometrics Transcutaneous TCPO2/CO2 Module (1998), 0 descendants of its own

## Indications for use
Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for patient popuhfiom including: adult, pediatric, and/ or neonatal. Use of the Marquetite Solar 9000 Anesthesia information Monitor is not recommended for use in patient’s home or residence, during patient transport, or when it has not been ordered by a physician or other quaiified personnel. Use of the Marquette Solar 9000 Anesthesia Information Monitor is intended for operating room (OR), post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive csre. These departments are typically located in hospitals or may be located in outpatient clinics or free standing surgical centers. It is intended for use by physicians, physician assistants, registered nurses, certified registered nurse anesthetists, or other hospital personnel trained in the use of the equipment.

Source page: https://510kreport.com/device/K954852
Methodology: https://510kreport.com/methodology