# K001359: Dash 3000/4000 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: General Electric Medical Systems Information Techn
- Decided: Jul 18, 2000 after 81 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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
No predicates in its family tree.
302 later devices descend from it; 2 cite it directly.
1 of 303 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020290: Dash 3000/4000 Patient Monitor (2002), 284 descendants of its own
- K030431: Modification to Dash 3000/4000 Patient Monitor (2003), 257 descendants of its own
- K042417: Zoll M Series ETC02 Loflo Option (2004), 238 descendants of its own
- K053174: Loflo C5 CO2 Sensor (2006), 237 descendants of its own
- K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors (2006), 222 descendants of its own

## Recalls of this device
- Aug 31, 2018 · Class II · Z-0520-2019: 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.

Source page: https://510kreport.com/device/K001359
Methodology: https://510kreport.com/methodology