Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)

The Electric Nasal Aspirator is a portable, battery-powered device intended for intermittent removal of nasal secretions and mucus from children ages 2–12 years in a home environment. It uses a motor pump to generate negative pressure that draws nasal secretions into a collection cup. The device includes multiple silicone nasal tips of different shapes and sizes to accommodate different children, and features user controls for vacuum pressure, along with music and light functions.

The subject device comprises six models (DT10, DT50, DX80, DX85, DX86, DX90) with minor differences in structure, suction levels, sound levels, battery capacity, and tip dimensions. DT10 and DT50 feature air tubes connecting the suction portion to the main unit and offer 6 suction levels, while DX80, DX85, DX86, and DX90 are fully integrated portable units with 5 suction levels. All models maintain the same 52–60 kPa vacuum pressure range as the predicate device and use 3.7V rechargeable lithium-ion batteries.

Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (skin irritation). Electrical safety and EMC: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62133-2 (battery safety), and IEC 62471 (photobiological safety). Performance testing included product life, suction, flow rate, automatic power-off, and noise testing.

The subject device has identical intended use and indications for use as the predicate device (K244033), uses equivalent motor-pump operating principles, and achieves the same 52–60 kPa vacuum pressure range. Although design differences exist in flow rate, battery capacity, dimensions, weight, and tip geometry, all performance tests demonstrate the device meets its predefined acceptance criteria. These differences do not raise safety or efficacy concerns, and biocompatibility and electrical safety testing confirm compliance with applicable standards.