# K012467: Solar 8000M System

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Feb 11, 2002 after 194 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (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.
100 later devices descend from it; 2 cite it directly.
1 of 104 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993757: SOLAR 7/8000, General Electric Medical Systems Information Techn (2000) Summary page 1.

## Most influential descendants
- 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
- K072581: PM-60 Pulse Oximeter (2008), 19 descendants of its own

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0523-2019: 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.
- Apr 2, 2008 · Not classified · Z-0285-2009: A software error has been discovered when using Combination Monitoring with Solar 8000M/i - PDM - Telemetry in combo mode. This error has only been noted with this particular configuration and mode of

## Indications for use
The Solar 8000M System is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in the use of the equipment. The Solar 8000M is a multiparameter physiclogical patient monitoring system intended for use on adult, pediatric and necnatal patients, within a hospital or facility environment. The Solar 8000M System is capable of monitoring electrocardiogram, invasive blood pressure, non-invasive bleod pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous O, saturation, Transcutaneous O, and CO; respiratory mechanics, and/or (for aduit and/or pediatric patients) anesthetic agent concentrations, impedance cardiography, electroencephalography and bispectral index. O, and CO, concentrations are available for neonates not under anesthesia. Information can be displayed, trended and stared in the monitor from a variety of peripheral devices. The Solar 8000M System is also intended to provide physiologic data over the UNITY ™ network. The Solar 8000M System was developed to interface with third party peripheral devices that support serial and/or analeg data outputs.

Source page: https://510kreport.com/device/K012467
Methodology: https://510kreport.com/methodology