# K993757: SOLAR 7/8000

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Mar 23, 2000 after 139 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). 2 ancestors in all.
116 later devices descend from it; 2 cite it directly.
5 of 119 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) Summary page 1.
- K921669: Marquette SL Series Transport Remote Acquisition, Marquette Electronics, Inc. (1993) Summary page 1.

## Most influential descendants
- K012467: Solar 8000M System (2002), 100 descendants of its own
- K071073: Solar 8000 and Transport Pro with Patient Data Module (2007), 51 descendants of its own
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express (2007), 47 descendants of its own
- K092027: Carescape Monitor B850 (2009), 38 descendants of its own
- K102239: Carescape Monitor B650 (2010), 32 descendants of its own

## Indications for use
The Solar 7/8000 System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of the system is to monitor physiologic parameter data on adult, pedlatnc and neonatal patients within a hospital or facility providing patient care. Physiologic parameter data includes: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, end tidal CO,, pulse oximetry, venous O, saturation, Transcutaneous O, and/or CO,, respiratory mechanics, and/or (for adult and/or pediatric patients) anesthetic agent concentrations. O, and/or CO, concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stored in the monitor from a variety of peripheral devices. The Solar 7/8000 System is also intended to provide physiologic data over the UNITY™ network. The Solar 7/8000 System was developed to interface with third party peripheral devices that support serial and/or analog data outputs.

Source page: https://510kreport.com/device/K993757
Methodology: https://510kreport.com/methodology