# K982499: Cosmo Plus with Nico, Model 8200

- Pathway: 510(k) (Traditional)
- Applicant: Novametrix Medical Systems, Inc.
- Decided: Oct 16, 1998 after 88 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
251 later devices descend from it; 3 cite it directly.
1 of 252 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030886: Nico with Mars, Model 7300 (2003), 246 descendants of its own
- K053522: Philips MP40, MP50, MP60, MP70, MP80 and MP90 Intellivue Patient Monitors, Release D.00 (2006), 233 descendants of its own
- K060221: The Phillips, Model MP20,MP30,MP40,MP50,MP60,MP70,MP80,and MP90 Intellivue Patient Monitors (2006), 222 descendants of its own
- K060541: The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient Monitors (2006), 221 descendants of its own
- K061052: The Philips Intellivue Patient Monitors, Models MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90 (2006), 211 descendants of its own

## 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 CO,SMO Plus! with NICO 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, carbon dioxide and pulse oximetry monitoring in neonatal, pediatric and adult patients during general anesthesia and in the intensive care unit (ICU) 4nd the emergency department (ED). Separate flow sensors and CO, airway adapters are provided for pediatric/adult and neonatal use. It is intended to be used by trained operators when spirometric, capnographic, pulse oximetry, or cardiac output monitoring is indicated in the judgement of a physician. Itis intended that: = the neonatal flow and combined CO,/flow sensors be used with ET tube sizes less than or equal to 4 mm and » the pediatric/adult flow and combined CO,/flow sensors be used with ET tube sizes greater than 4 mm or with 22 mm ID breathing circuit devices such as a mouthpiece. The fittings of the flow sensors and CO, airway adapters comply with ISO [5356-1: 1987 (E)]. The flow sensors and CO, airway adapters may be used in conjunction with endotracheal tubes, face masks, and breathing circuit devices that also comply with the same fitting specification. The flow sensors, combination CO /flow sensors, single patient use CO, airway adapters and valve assembly are single patient use devices. The CO,SMO Plus! with NICO can calculate additional parameters such as cardiac output, pulmonary capillary blood flow, cardiac index, stroke volume and systemic vascular resistance. The use of the CO,SMO Plus! with NICO is contraindicated in patients in which a smali rise (3-5 mmHg) in their arterial partial pressure of CO, level cannot be tolerated.

Source page: https://510kreport.com/device/K982499
Methodology: https://510kreport.com/methodology