# K101123: Nexfin Model 2

- Pathway: 510(k) (Traditional)
- Applicant: Bmeye B.V.
- Decided: Oct 28, 2010 after 189 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: 7 generations back to K000126 (2000). 15 ancestors in all.
54 later devices descend from it; 1 cites it directly.
1 of 70 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics, Bmeye B.V. (2007) Summary page 1.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 1.

## Most influential descendants
- 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
- K180881: HemoSphere Advanced Monitor, HemoSphere Pressure Cable (2018), 40 descendants of its own

## Indications for use
The BMEYE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamnic parameters, functional saturation of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The pulse-oximetry component of CC Nexfin is indicated for use during both no motion and motion conditions and for patients who are well or poorly perfused. The CC Nexfin monitor does not feature (physiological) alarms, therefore the continuous availability of pulse-oximetry data should be treated as a series of spot-checks rather than continuous monitoring. The CC Nexfin monitor should be calibrated with a thermodilution measurement, or other accurate reference estimation of cardiac output, to ensure optimal accuracy of cardiac output. The device is intended for use by physicians or other properly trained medical personnel in a hospital or other appropriate clinical selling.

Source page: https://510kreport.com/device/K101123
Methodology: https://510kreport.com/methodology