# K012915: Dinamap Pro 1000 Monitor, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: Mar 21, 2002 after 203 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: 1 generation back to K001359 (2000). 2 ancestors in all.
27 later devices descend from it; 2 cite it directly.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002248: Dinamap Pro 1000 Monitor, Model 1000, Critikon Company, LLC (2000) Summary page 1.
- K001359: Dash 3000/4000 Patient Monitor, General Electric Medical Systems Information Techn (2000) Summary page 2.

## Most influential descendants
- K022834: Dinamap Pro 1000 Monitor with Superstat, Model 1000 (2003), 23 descendants of its own
- K073203: Carescape V100 (2007), 20 descendants of its own
- K102426: Carescape Model V100 Vital Signs Monitor (2010), 11 descendants of its own
- K120598: Procare Monitor B40 (2012), 10 descendants of its own
- K130584: Monitor B40 (2013), 8 descendants of its own

## Recalls of this device
- Apr 30, 2003 · Not classified · Z-0011-04: Reports of broken plug ground pins on AC power cords for patient monitors.

## Indications for use
The DINAMAP® Pro 1000 V2 Monitor is intended to monitor oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, oxygen saturation (SpO,) by non-invasive pulse oximetry, and predictive temperature with an electronic 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 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/K012915
Methodology: https://510kreport.com/methodology