FDA 510(k) Clearance For Covidien’s Nellcor™ Bedside SpO2 Patient Monitoring System

In short

If medtech companies were like Olympic nations, Covidien would be USA…. appearing in all the big events and usually winning. It’s certainly entered the patient monitoring and respiratory care solutions event and has to be fancied with its newly announced  FDA 510(k) clearance to market its Covidien Nellcor™ Bedside SpO2 Patient Monitoring System.


The Nellcor Bedside SpO2 system with OxiMax™ technology continuously monitors SpO2 and pulse rate for adult, paediatric and neonatal patients, giving clinicians instant access to comprehensive trending respiratory information. The company claims this enables clinicians to detect subtle, yet critical, heart rate and SpO2 variations earlier and thus address respiratory complications sooner.

The Nellcor Bedside SpO2 Patient Monitoring System also features enhanced digital signal processing for precise SpO2 readings during low perfusion or other challenging conditions that make it difficult to accurately track these patients. Its SatSeconds™ alarm management technology differentiates between serious and minor events to reduce clinically insignificant oxygen desaturation alarms.

Covidien says the system monitor’s multicolor screen is easy to read in any light and from many angles.

What is interesting from a hospital maintenance perspective is that technicians can set their own institutional defaults, replace the battery, perform diagnostics and generally maintain the monitor within the hospital, saving time and resources.

Company comments

“We are pleased to announce the new Covidien Nellcor Bedside SpO2 Patient Monitoring System is approved for commercial release in the United States,” said Robert J. White, President, Respiratory and Monitoring Solutions, Covidien. “Healthcare professionals on the general care floor, and in other lower- acuity areas of the hospital, need critical patient information at their fingertips so they can respond quickly to health threats. By giving them ready access to a patient’s respiratory history, the system allows them to focus on delivering efficient, high-quality care, not gathering and managing data.”

Regulatory status

The Nellcor Bedside SpO2 Patient Monitoring System meets medical electrical equipment safety standards, including IEC 60601-1:2005, and complies with the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) directive for products sold in European Economic Area markets.

Source: Covidien, Business Wire