# K160967: Finapres Nova Noninvasive Hemodynamic Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Finapres Medical Systems B.V.
- Decided: Apr 18, 2017 after 377 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: 9 generations back to K902859 (1991). 79 ancestors in all.
3 later devices descend from it; 1 cites it directly.
4 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141460: Finapres Nova Noninvasive Hemodynamic Monitor, Finapres Medical Systems B.V. (2015) Summary page 5.
- K014063: Task Force Monitor 3040, Cnsystems Medizintechnik GmbH (2002) Summary page 6.

## Most influential descendants
- K173916: Finapres Nova Noninvasive Hemodynamic Monitor (2018), 2 descendants of its own
- K223332: Task Force CORE (2023), 0 descendants of its own
- K190228: Transcranial Doppler Ultrasound System (2019), 0 descendants of its own

## Indications for use
The Finapres NOVA is intended to be used with patients who have a need for a noninvasive blood pressure and hemodynamic monitor. The noninvasive blood pressure waveform is measured on the subject’s finger. The Finapres NOVA provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow and in various hemodynamic parameters derived from these pressure and flow signals, such as heart rate variability (HRV) and Baroreflex sensitivity (BRS). Cardiac output derived from the flow signal requires a calibration with thermal dilution. The Finapres NOVA has the option to include additional modules to extend its functionality with ECG and SpO2 measurements and blood pressure calibration. When the SpO2 module is present, the Finapres NOVA can additionally monitor the functional oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate. When the ECG module is present, the Finapres NOVA can additionally monitor the ECG parameters of a patient and their pulse rate. Alarms concerning the pulse rate will be available from the monitor. When the blood pressure calibration module is present, the Finapres NOVA can additionally provide an upper arm non-invasive blood pressure measurement to determine the blood pressure value for calibration. The Finapres NOVA is intended to be used for subjects above 18 years of age. The Finapres NOVA is intended for use in hospitals, clinics and research institutions.

Source page: https://510kreport.com/device/K160967
Methodology: https://510kreport.com/methodology