Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U103-117); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U410-121); Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U110-121)

The Unimed Reusable SpO2 Sensors are pulse oximeter sensors designed for continuous non-invasive monitoring of blood oxygen saturation (SpO2) and pulse rate in adult patients weighing over 30 kg and pediatric patients weighing 10–50 kg. Available in multiple configurations (finger clip, wrap, soft-tip), these reusable sensors are compatible with GE B40i monitors and are for prescription use only.

The subject devices use two-wavelength relative optical absorption (660nm/880nm/940nm) with an LED and photodetector in a finger clip configuration. They demonstrate SpO2 accuracy of ±3% (no motion, 70–100% saturation range) and pulse rate accuracy of ±2 bpm (30–250 bpm). Operating temperature range is 5–40°C with operational/storage humidity of 10–85%. Materials include silicone pads and plastic housing designed for prolonged skin contact.

IEC 60601-1 (general electrical safety), IEC 60601-1-2 (electromagnetic compatibility), ISO 80601-2-61 (pulse oximeter equipment), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (skin irritation). Clinical validation followed ISO 80601-2-61 and FDA guidance on pulse oximeter premarket notification submissions.

Both the subject device and predicate (TruSignal SpO2 sensors, K093881) operate on identical two-wavelength optical absorption principles, are reusable Rx-only sensors, and share the same regulatory classification (Class II, 21 CFR 870.2700). While the subject device's SpO2 accuracy (±3%) is slightly broader than the predicate (±2%), both meet FDA guidance thresholds. Pulse rate accuracy, biocompatibility testing, and environmental operating parameters are equivalent or meet recognized standards. Clinical hypoxia testing with adequate representation of darkly pigmented subjects (Fitzpatrick Type 5–6) validated the subject device's accuracy claims over the specified range.