# K041907: Trio Monitor

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Jul 23, 2004 after 8 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
Longest line of descent: 4 generations back to K933143 (1994). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032338: Trio Monitor Model 0998-00-0600, Datascope Corp. (2004) Summary page 1.
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX, Datascope Corp. (2000) Summary page 1.

## Indications for use
The Trio TM 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/K041907
Methodology: https://510kreport.com/methodology