# K183521: CNAP Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Cnsystems Medizintechnik GmbH
- Decided: Sep 11, 2019 after 266 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: 11 generations back to K000126 (2000). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 40 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082599: Non-Invasive Continuous Blood Pressure Monitoring System Cnap Monitor 500I, 500AT, Cnsystem Medizintechnik AG (2008) Summary page 5.
- K160552: EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform, Edwards Lifesciences, LLC (2016) Summary page 5.
- K172259: PulsioFlex Monitoring System, Pulsion Medical Systems SE (2018) Summary page 5.

## Most influential descendants
- K223332: Task Force CORE (2023), 0 descendants of its own

## Indications for use
The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters. Alarms are generated for blood pressure parameters and pulse rate. The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals.

Source page: https://510kreport.com/device/K183521
Methodology: https://510kreport.com/methodology