# K070500: Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim

- Pathway: 510(k) (Traditional)
- Applicant: Ni Medical
- Decided: Jul 16, 2007 after 145 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: 1 generation back to K942227 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942227: Nicas 2001 Noninvasive Cardio-Respiratory System, C.L. Mcintosh & Assoc., Inc. (1996) Summary page 2.

## Most influential descendants
- K080941: Bioimpedance Cardiac Analyzing Measuring System (2009), 0 descendants of its own

## Indications for use
The NICaS 2004 Slim is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance), in males and females needing cardiac output assessment, including patients with cardiac disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

Source page: https://510kreport.com/device/K070500
Methodology: https://510kreport.com/methodology