Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)

The Unimed Reusable Finger Clip SpO2 Sensors (models U403-49R and U103-49R) are non-invasive pulse oximeter sensors that continuously monitor oxygen saturation (SpO2) and pulse rate in adult patients over 30 kg and pediatric patients weighing 10–50 kg. These prescription-only, reusable sensors connect to compatible Masimo monitors and consist of a connector, cable, LED, photodetector, and finger clip.

The subject devices differ from the predicate (K242580) only in the interface connector type: the new models use a DB9 connector instead of a card-edge connector. All other components—LED wavelengths (660nm/905nm), photodetector, cable composition, finger clip material (ABS), biocompatible silicone pad, and patient-contacting surfaces—remain identical to the predicate device.

Testing was conducted per IEC 60601-1 (general safety and essential performance), IEC 60601-1-2 (electromagnetic disturbances), ISO 80601-2-61 (pulse oximeter equipment requirements), and ISO 10993 series (biocompatibility including cytotoxicity, skin sensitization, and skin irritation assessments).

The devices are substantially equivalent because only the connector interface changed while all electro-optical components, patient-contacting materials, clinical performance specifications, and biocompatibility data remain unchanged from the predicate. Verification testing confirmed the connector modification does not adversely affect safety or performance, and prior clinical and biocompatibility data remain applicable.