# K032338: Trio Monitor Model 0998-00-0600

- Pathway: 510(k) (Abbreviated)
- Applicant: Datascope Corp.
- Decided: Feb 11, 2004 after 197 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) GE Medical Systems Dash 2000 Pro Patient Monitor: named in the summary without a submission number

## Most influential descendants
- K041907: Trio Monitor (2004), 0 descendants of its own

## Recalls of this device
- Sep 24, 2004 · Not classified · Z-0018-05: Software anomaly where the variable heart rates may be displayed inaccurately or intermittent 'dashes' may be displayed when the patient's heart rate is derived from ECG.
- Jul 28, 2004 · Not classified · Z-1483-04: The Trio Monitor has latex feet. It is not labeled per 21 CFR801.437 to indicate that it contains latex.

## Indications for use
The TrioTM monitor is intended for hospital use 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, noninvasive blood pressure, pulse oximetry, heart rate (derived from ECG or SpO2), 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/K032338
Methodology: https://510kreport.com/methodology