# K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics

- Pathway: 510(k) (Traditional)
- Applicant: Bmeye B.V.
- Decided: Nov 29, 2007 after 127 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: 3 generations back to K880572 (1988). 5 ancestors in all.
78 later devices descend from it; 6 cite it directly.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023723: Finometer Noninvasive Hemodynamic Monitor, Model 1, Fms, Finapres Medical Systems BV (2003) Summary page 1.

## Most influential descendants
- K101123: Nexfin Model 2 (2010), 54 descendants of its own
- K122381: Nexfin Model 2 (2013), 53 descendants of its own
- K140312: EV1000 Clinical Platform with Clearsight TM Finger Cuff or Clearsight TM System (2014), 52 descendants of its own
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform (2016), 51 descendants of its own
- K163381: HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable (2017), 41 descendants of its own

## Indications for use
The BMEYE NEXFIN._HD is intended to, non-invasively and continuously, measure blood pressure and hemodynamic parameters in adult patients. The NEXFINHD monitor should be calibrated with a thermodilution measurement, or other accurate reference determination of cardiac output, to ensure optimal accuracy. The device is Intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical setting.

Source page: https://510kreport.com/device/K072049
Methodology: https://510kreport.com/methodology