# K031376: Dinamap Pro 1000 V3 Monitor, Model 1100 Series

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Jul 16, 2003 after 76 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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: 2 generations back to K001359 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012915: Dinamap Pro 1000 Monitor, Model 1000, Ge Medical Systems Information Technologies (2002)

## Most influential descendants
- K080157: Dash 2500 Patient Monitor (2008), 1 descendant of its own
- K090702: Modification to Dash 2500 Patient Monitor (2009), 0 descendants of its own

## Indications for use
The DINAMAPB Pro 1000 V3 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heaNpulse rate, respiration rate, ECG, oxygen saturation (Sp02) by non-invasive pulse oximetry, and predictive temperature with an electrclnic thermometer in the adult, pediatric and neonate populations. An additional feature is the detection of three lethal arrhythmias- asystole, ventricular tachycardia (v-tach), and ventricular fibrillation (v-fib). The Pro 1000 V3 Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.

Source page: https://510kreport.com/device/K031376
Methodology: https://510kreport.com/methodology