Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)

The Electric Nasal Aspirator (models BC026, BC025, BC023, BC028, BC029, BC036) 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 uses a motor pump to create negative pressure (50-62 kPa) for nasal passage cleaning, with adjustable flow levels and features like music, light, and pause functions on select models.

Subject device differs from predicate in vacuum pressure range (50-62 kPa vs. 52-60 kPa), air flow rates (three levels ranging 1.5-5 L/min with model variations), motor voltage (DC 3.0V vs. 3.7V), power consumption (2.55W vs. 2.2W), and physical dimensions/weight across six models. Some models include pause and light functions absent in predicate. Suction tip dimensions vary slightly. All models use identical materials (ABS, PC, Silicone) and identical power source (DC 3.7V/700mAh rechargeable Li-ion battery).

ES60601-1:2005/(R)2012 & amendments (electrical safety), IEC 60601-1-2:2020 (EMC), IEC 60601-1-11:2020 (home healthcare environment), ISO 10993-1:2018 (biocompatibility), ANSI AAMI IEC 62304:2006/A1:2016 (software), IEC 62133-2:2017 (lithium battery safety), IEC 62471:2006 (lamp safety), and enterprise performance standards.

The subject device is substantially equivalent to predicate K250697 because it has identical intended use (nasal secretion removal in children 2-12 years, home use), same device classification (Class II, BTA, 21 CFR 878.4780), identical patient contact materials (silicone), and complies with all applicable safety and performance standards. Minor differences in vacuum pressure, motor specifications, dimensions, and optional features (light, pause functions) do not affect substantial equivalence because both devices provide sufficient suction and meet electrical safety and performance testing requirements.