FL-10000U Respiratory Humidifier

The FL-10000U Respiratory Humidifier is an electrically powered device that warms and adds humidity to respiratory gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance through an endotracheal tube or face mask. It is intended for use by trained personnel in hospital/institutional settings and works with the Flexicare Autofill Humidification Chamber and Heated Wire Breathing Circuit.

The device has two heating control units with two temperature sensors, a heater plate (150 W) that warms water in a humidification chamber, heated wire adaptors (22V~, 2.73A, 60W) that maintain gas temperature in breathing tubes, and temperature probes that control chamber conditions. Physical specifications are identical to the predicate: 156mm × 170mm × 130mm, 2.9kg, 115V~ supply, 2.0A max current, with operating range 50/60 Hz. The recommended flow range differs slightly: subject device specifies minimum 1.5 lpm at PEEP ≥3 cmH₂O for invasive and max 60 lpm for non-invasive, versus predicate's up to 60 L/min invasive and 120 L/min non-invasive.

ISO 80601-2-74 (respiratory humidifying equipment), ISO 10993-1 (biocompatibility), ISO 18562-1 (breathing gas pathways), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), IEC 62366-1 (usability), IEC 62304 (software lifecycle), ISO 3744 (acoustic noise), and IEC 60529 (ingress protection).

The FL-10000U is substantially equivalent to the predicate FL-9000U because both devices share identical regulatory classification (Class II, 21 CFR 868.5450), product code (BTT), intended use (warming and humidifying respiratory gases for ventilated patients), design principles (two heating control units with temperature sensors, heated wire adaptors, pass-over heating method), physical dimensions, electrical specifications, and performance criteria including humidity output and alarm thresholds. Performance testing and standards compliance demonstrate the subject device meets the same safety and performance requirements as the predicate.