Babyleo TN500

The Babyleo TN500 is a hybrid neonatal warming device that functions as both an incubator and radiant warmer for neonates and infants up to 10 kg body weight. It provides controlled ambient conditions including temperature, humidity, and optional oxygen enrichment, with three synchronized heat sources: a radiant warmer, convective heater, and optional heated mattress.

Key differences from predicate K182859 include: an integrated rechargeable LiFePO4 battery option enabling intrahospital transport in incubator mode (45-minute runtime, 240-minute charge time); new processor board M48 with cooling fan and cybersecurity enhancements replacing processor board M16; software version 2.01.00 with transport functionality and extended cybersecurity features; and removal of lacquer coating from bed support and scale components while maintaining the same base material.

Testing per IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-19 (infant incubators), IEC 60601-2-21 (infant radiant warmers), IEC 62304 (software lifecycle), ISO 10993-1 (biocompatibility), ISO 14971 (risk management), IEC 62133-2 (lithium battery safety), and ISO 17664-2 (device processing).

The subject device is substantially equivalent to predicate K182859 because both share the same intended use (hybrid incubator/radiant warmer for neonates and infants), same regulatory class and product code, and substantially identical technological features including radiant warmer operation, incubator operation with humidification and oxygen supply, height adjustment, and alarm systems. The added battery feature and processor upgrade support the same therapeutic function without introducing new safety or effectiveness concerns, supported by comprehensive testing per applicable standards.