Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)

The Ear Thermometer (EAR-E101, EAR-E102, EAR-E103) is a handheld infrared thermometer that measures human body temperature by detecting thermal radiation from the eardrum. It displays results in °C or °F on an LCD screen and is powered by alkaline batteries. The device is intended for both professional and home use in people over three months of age.

All three models use a thermopile sensor to detect infrared thermal energy, operate in adjusted mode, and share the same critical components (sensor, PCB, buttons, LCD display, housing). The subject device has a measurement range of 32.0°C–42.9°C with ±0.2°C/±0.4°F accuracy, stores 40 temperature values, and powers off within 30 seconds. Differences from the predicate include narrower intended population (excludes infants under 3 months), different dimensions and battery types (AA or AAA versus AAA-only), and increased memory capacity.

IEC 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic compatibility), ISO 80601-2-56 (clinical thermometer requirements), IEC 60601-1-11 (home healthcare environment), ISO 10993-1/5/10/23 (biocompatibility including cytotoxicity, sensitization, and irritation), and FDA guidance on clinical electronic thermometer 510(k) submissions.

The subject device is substantially equivalent because it shares the same working principle, intended use, measurement site (eardrum), sensor technology (thermopile), and regulatory classification (Class II, product code FLL) as the predicate. Although differences exist in measurement range, memory capacity, dimensions, and patient population scope, these do not raise new safety or effectiveness questions; the narrower population actually reduces risk, the measurement range remains clinically appropriate, and all performance specifications meet or exceed predicate standards. Bench and clinical testing demonstrate equivalent accuracy and safety performance per ISO 80601-2-56, and biocompatibility testing confirms the materials pose no new risks.