# K022834: Dinamap Pro 1000 Monitor with Superstat, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems Information Technologies
- Decided: May 13, 2003 after 260 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.
23 later devices descend from it; 2 cite it directly.
1 of 27 devices in its family (counting itself) has 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
- 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
- K133576: Monitor B40 (2014), 7 descendants of its own

## Indications for use
The DINAMAPB Pro 1000 with SuperStat Monitor is intended to monitor the following adult, pediatric and neonate patient vital signs: Non-Invasive Blood Presure: *Able to measure oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure) *Will optimize performance in the presence of artifact due to vibration and patient motion. ~Non-invasive blood pressure determinations acquired concurrently with the ECG parameter will report a determination in the presence of an irregular heart rhythm in the adultlpediatric mode. Headpulse rate, respiration rate, ECG Oxygen saturation (SpO2) by noninvasive pulse oximetry and Predictive temperature by resistive thermometry. The Pro 1000 with SuperStat Monitor also detects alarm limit conditions and is capable of recording up to two waveforms. Using the monitor a clinician can view, record and recall clinical data derived from each parameter.

Source page: https://510kreport.com/device/K022834
Methodology: https://510kreport.com/methodology