# K091414: Vtrust Blood Pressure Monitor, Model Vtrust 701DH

- Pathway: 510(k) (Traditional)
- Applicant: Biocare Corp.
- Decided: Oct 21, 2009 after 161 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910852 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910852: 507 Non-Invasive Vital Signs Monitor, Criticare Systems, Inc. (1991) Summary page 1.

## Indications for use
The BioCare vTrust 701DH NIBP monitor is a compact, battery-powered monitor which measures noninvasive blood pressure (systolic, diastolic and mean arterial pressure) and pulse rate based on the principle of plethysmography (oscillometric on inflation). This equipment is intended for use only by qualified medical providers in conjunction with established medical protocols. It is not intended for use in an MRI environment, or in an air transport environment.

Source page: https://510kreport.com/device/K091414
Methodology: https://510kreport.com/methodology