# K122381: Nexfin Model 2

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 22, 2013 after 259 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: 8 generations back to K000126 (2000). 16 ancestors in all.
53 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)
- K101123: Nexfin Model 2, Bmeye B.V. (2010)

## Most influential descendants
- 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
- K190205: HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module (2019), 34 descendants of its own

## Indications for use
The SMEVE CC Nexfin is intended to, non-invasively and continuously, measure blood pressure, hemodynamic parameters, functional saturation of arterial hemoglobin (SpO2), and total hemoglobin concentration (SpHb) in adult patients. The pulse-oximetry component of CC Nexfln 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 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/K122381
Methodology: https://510kreport.com/methodology