# K992929: Dash 3000 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Nov 26, 1999 after 87 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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: 1 generation back to K921669 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Cited in the summary but kept off the family tree
- K984750: Eagle 4000 Patient Monitor. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0519-2019: 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.
- Nov 27, 2013 · Class II · Z-0982-2014: GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash Port 2 Docking Station: DASH: 1. Dash stops communicating on the Unity Network resulting in Loss of Mo

## Indications for use
The Dash 3000 Patient 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. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centorg, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e., ambulance, etc.) and fixed and rotary winged aircraft, and pre-hospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. Other features include arrhythmia, cardiac output, cardiac and puimonary calculations, dose calculations, PA wedge, ST analysis, and interpretive 12 lead ECG analysis (12SL). The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical infurmaltion syslems dand allow the user o aceess hospital data at the point-of-care. This information can be displayed, trended, stored, and printed.

Source page: https://510kreport.com/device/K992929
Methodology: https://510kreport.com/methodology