Covidien has received FDA 510(k) clearance for motion claims for three of its Nellcor pulse oximetry products, which are used to measure arterial oxygen saturation.
Notably, the approvals make Covidien the first company to receive FDA clearance for a motion-tolerant bedside pulse oximeter portfolio that is also compliant with International Organization for Standardization standards (ISO 80601-2-61), according to Covidien.
The devices covered by the action include:
- Nellcor Bedside SpO2 Patient Monitoring System
- Nellcor Bedside Respiratory Patient Monitoring System
- NellcorN-600x Pulse Oximetry Monitoring System
Nellcor devices rely on cardiac-based signals to provide a more accurate reading that is closely tied to the patient’s physiology, according to the company. Motion-tolerant pulse oximetry is critical for ensuring patient safety because patient movement can thwart accurate readings and delay diagnosis of serious respiratory compromise.
“For more than 30 years, clinicians have trusted Nellcor pulse oximetry to monitor their patients,” said Robert J. White, president of Respiratory and Monitoring Solutions for 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.”
All three Nellcor pulse oximetry devices are prescription-use only and designed for neonatal, pediatric, and adult patients, and for well or poorly perfused patients in hospitals, hospital-type facilities, intra-hospital transport and home environments, according to Covidien.