731 Series Ventilator

The ZOLL 731 Series Ventilator is a portable mechanical ventilator for infants (≥5 kg), pediatric, and adult patients with acute or chronic respiratory failure. It operates in hospitals, prehospital settings, and field environments, providing multiple ventilation modes including AC, SIMV, CPAP, and NPPV. The device includes an integrated pulse oximeter with Masimo SET technology for continuous SpO2 and heart rate monitoring.

The primary technological change from the predicate device (K162832, cleared 2017) is the introduction of software revision 5.25, which updates the ventilator alarm logic. This revision improves patient-ventilator interaction and alarm detection, specifically targeting better functionality with COVID-19 patients. The principles of operation, indications for use, and all other design features remain identical to the predicate.

The device was tested to compliance with 24 international standards including EN 794-3, EN ISO 15223-1, ISO 20417, EN 60601-1 series (electrical safety), EN 62304 (software lifecycle), EN ISO 10993 series (biocompatibility), EN ISO 80601-2-61 (medical ventilators), EN ISO 14971 (risk management), and environmental standards including MIL-STD-810G and RTCA/DO-160.

Substantial equivalence is established because the software revision 5.25 change is limited to alarm logic improvements without altering the fundamental principles of operation, clinical indications, intended use, or patient safety profile. Software verification and validation testing confirmed the device meets all functional requirements and performance specifications equivalent to the predicate. The user interface remains unchanged, and no modifications were made to alarm audio/visual annunciation or control mechanisms.