# K051897: Trio Monitor

- Pathway: 510(k) (Special)
- Applicant: Datascope Corp.
- Decided: Aug 12, 2005 after 30 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The TrioTM monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor

Source page: https://510kreport.com/device/K051897
Methodology: https://510kreport.com/methodology