Electric Nasal Aspirator (BC026, BC025, BC023)

The Electric Nasal Aspirator is a portable, battery-powered suction device intended for intermittent removal of nasal secretions and mucus from children ages 2-12 years in a home environment. It operates via a motor pump that generates negative pressure (52-60 kPa) controlled through user buttons, with optional features like music and light functions to distract the child.

The device comes in three models (BC026, BC025, BC023) with minor variations: BC026 has 5 suction levels and light/pause features; BC025 and BC023 have 3 suction levels with BC023 including light/pause. All models use a 3.7V DC rechargeable Li-ion battery (700 mAh), operate at <80 dBA noise level, weigh 305-320g, and have identical silicone nasal tips (OD4.3/ID2.4 mm). Dimensions vary slightly but patient-contact parts are identical across models.

Safety: IEC 60601-1, IEC 60601-1-11, IEC 62133-2, IEC 62471. EMC: IEC 60601-1-2 and IEC TR 60601-4-2. Biocompatibility: ISO 10993-1:2018. Software: ANSI AAMI IEC 62304. Home healthcare: IEC 60601-1-11:2020. All tests confirmed device conformance.

The subject device shares identical intended use, patient population (ages 2-12), home environment, vacuum pressure range, and patient-contact materials (silicone tips) with predicate BC026. The three models have substantially the same technological characteristics and safety performance; differences in suction levels, light function, and minor dimensional variations do not raise new safety questions because the light function is optional and the patient-contact part is identical across all models. All devices passed identical safety and EMC standards, demonstrating equivalent safety and effectiveness profiles to the predicate.