# K942227: Nicas 2001 Noninvasive Cardio-Respiratory System

- Pathway: 510(k) (Traditional)
- Applicant: C.L. Mcintosh & Assoc., Inc.
- Decided: Jun 28, 1996 after 784 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BoMed NCCOM3-R7 Monitor: named in the summary without a submission number

## Most influential descendants
- K070500: Bioimpedance Cardiac Analyzing Measuring System, Model Nicas 2004 Slim (2007), 1 descendant of its own
- K080941: Bioimpedance Cardiac Analyzing Measuring System (2009), 0 descendants of its own
- K972001: Nicas (TM) Electrode (1997), 0 descendants of its own

## Indications for use
The NICaS 2001 is intended for use in monitoring hemodynamic parameters (including stroke volume, stroke index, heart rate, cardiac index, cardiac output, and total peripheral resistance) and ventilatory parameters (respiratory rate) in males and females needing cardiac output assessment, including patients with cardiovascular disorders, patients undergoing cardiac catheterization, cardiac surgery patients and patients in intensive and cardiac care units and rehabilitation.

Source page: https://510kreport.com/device/K942227
Methodology: https://510kreport.com/methodology