FDA Clears Covidien’s Nellcor™ Pulse Oximetry Motion Claims

covidien nellcorLast October Covidien’s Nellcor™ pulse oximetry portfolio gained its original FDA clearance as we reported here. Now the system, which is used to measure arterial oxygen saturation, has received U.S. FDA 510(k) clearance for so-called “motion” claims. This makes Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with ISO 80601-2-61 (International Organization for Standardization standards for pulse oximetry).

Background

Pulse oximeters provide early warning of dangerous respiratory complications, enabling clinicians to detect and address life-threatening events sooner. Nellcor devices rely on cardiac-based signals to provide a more accurate reading that is closely tied to the patient’s physiology. This drives consistent performance during various challenging conditions, such as patient motion, noise and low perfusion, which can impede the assessment of patient respiratory status.

Motion-tolerant pulse oximetry is critical for ensuring patient safety because patient movement can thwart accurate readings and delay diagnosis of serious respiratory compromise.

Devices covered by the action include:

Nellcor Bedside SpO2 Patient Monitoring System

Nellcor Bedside Respiratory Patient Monitoring System

NellcorN-600x Pulse Oximetry Monitoring System

Company comments

“For more than 30 years, clinicians have trusted Nellcor pulse oximetry to monitor their patients,” said Robert J. White, President, Respiratory and Monitoring Solutions, Covidien. “The FDA’s recent clearance of motion-tolerance claims should now give clinicians added comfort that they’re providing the highest standard of patient care.”

Source: Covidien, Business Wire