# K041450: Modification to Nico with Mars, Model 7300

- Pathway: 510(k) (Special)
- Applicant: Respironics Novametrix, Inc.
- Decided: Jun 18, 2004 after 17 days
- Product code: CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase)
- Device class: 2
- Regulation: 21 CFR 868.1400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K962603 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030886: Nico with Mars, Model 7300, Respironics Novametrix, Inc. (2003) Summary page 1.

## Recalls of this device
- Aug 11, 2006 · Not classified · Z-1535-06: Audible alarm may not sound during an alert condition

## Indications for use
The intended use of the NICO with MARS, Model 7300, monitor is to provide: * cardiac output monitoring via the method of partial rebreathing in adult patients receiving mechanical ventilation during general anesthesia and in the intensive care unit (ICU). * spirometric and carbon dioxide monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). Separate combination C02/flow sensors are provided for adult, pediatric and neonatal use. * continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate in neonatal, pediatric and adult patients during both no motion and motion conditions and for patients who are well or poorly perfused during general anesthesia and in the intensive care unit (ICU) and the emergency department (ED). The use of the NICO with MARS, Model 7300, monitor for cardiac output monitoring is contraindicated in patients in which a small rise (3-5 mmHg) in their arterial partial pressure of CO 2 level cannot be tolerated.

Source page: https://510kreport.com/device/K041450
Methodology: https://510kreport.com/methodology