# K051367: Patient Monitor, Models Dash 3000, 4000 and 5000

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jun 20, 2005 after 26 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: 6 generations back to K963644 (1996). 24 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033304: Modification to Dash 3000/4000 Patient Monitor, Ge Medical Systems Information Technologies (2003) Summary page 1.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K983684: Datex-Ohmeda 3800+/3800P+ or 3900/3900P Pulse Oximeters, Datex-Ohmeda, Inc. (1998) Summary page 1.
- K040183: BISX, Aspect Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K073462: Modification to Dash 3000, 4000, 5000 Monitor and Accessories (2008), 8 descendants of its own
- K080461: Star ST and Arrhythmia Software, Release J.0 (2008), 6 descendants of its own
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O (2010), 4 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K152305: Nihon Kohden Afib Detection Program QP-039P (2016), 0 descendants of its own

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0521-2019: 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 DASH 3000/4000/5000 Patient Monitor 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 3000/4000/5000 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 centers, 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, carbon dioxide, oxygen, and anesthetic agents as summarized in the operators manual. The DASH 3000/4000/5000 Patient Monitor is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed. The DASH 3000/4000/5000 Patient Monitor was developed to interface with non-proprietary third party peripheral devices that support serial data outputs.

Source page: https://510kreport.com/device/K051367
Methodology: https://510kreport.com/methodology