# K080941: Bioimpedance Cardiac Analyzing Measuring System

- Pathway: 510(k) (Traditional)
- Applicant: N.I. Medical, Ltd.
- Decided: Jun 18, 2009 after 441 days
- Product code: DSB (Plethysmograph, Impedance)
- Device class: 2
- Regulation: 21 CFR 870.2770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K895520 (1990). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070500: Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim, Ni Medical (2007) Summary page 1.
- K070156: Bioz DX Hemodynamic Monitor with Philips 12-Lead Ecg, Model 5100, Cardiodynamics International Corp. (2007) Summary page 1.

## Indications for use
The NICaS CS is intended to monitor and display a patients hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, total peripheral resistance, and the Granov-Goor Index), in males and females with known or suspected cardiac disorders needing cardiac assessment.

Source page: https://510kreport.com/device/K080941
Methodology: https://510kreport.com/methodology