# K023723: Finometer Noninvasive Hemodynamic Monitor, Model 1

- Pathway: 510(k) (Traditional)
- Applicant: Fms, Finapres Medical Systems BV
- Decided: Oct 23, 2003 after 352 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: 2 generations back to K880572 (1988). 4 ancestors in all.
81 later devices descend from it; 3 cite it directly.
1 of 86 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K822055: Cnibp Blood Pressure Measurement Sys, Ohio Medical Products (1982) Summary page 2.
- K880572: Ohmeda 2350 Finapres (R) Blood Pressure Monitor, Ohmeda Medical (1988) Summary page 2.
- K014063: Task Force Monitor 3040, Cnsystems Medizintechnik GmbH (2002)

## Most influential descendants
- K072049: Continuous Non-Invasive Cardiac Output and Blood Pressure Monitor with Real-Time Hemodynamics (2007), 78 descendants of its own
- 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

## Indications for use
The Finometer is intended to be used when there is a need for a noninvasive hemodynamic monitor. The Finometer provides a noninvasive characterization of the arterial circulation and its beat-to-beat variability in pressure and flow as well as in various hemodynamic parameters derived from these pressure and flow signals. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers. The noninvasively blood pressure waveform is measured by using the Finapres method of PeiiWesseling. Hemodynamic parameters include cardiac output and total peripheral resistance based on the Modelflow method of Wesseling. The Finometer is intended to be installed and operated by a qualified physician or operator Pressure measurements are validated for subjects above 18 years of age. The only mode of measuring blood pressure accurately is when the device is used with the return-to-flow method of calibration, if the pressure data are t a comply with the recommendations of the AAMI SPlO standard. Modelflow built-in calibration is usehl from 18 years on. Cardiac output measured with this device under the Modelflow model requires a calibration with thermal dilution. The physiological parameters provided by the device have clinical significance only if determined by a physician and should not be used as the sole means for a patient's diagnosis. The data provided by the device can be hrther processed by the included PC-based BeatScope software.

Source page: https://510kreport.com/device/K023723
Methodology: https://510kreport.com/methodology