Babyroo TN300

The Babyroo TN300 is an open care radiant warmer for neonates and infants up to 10 kg that provides controlled heat and skin temperature regulation. It includes optional integrated resuscitation, weighing, and pulse oximetry functions. The device is used in labor/delivery, NICU, pediatric ICU, and operating room settings.

The subject device activates existing but previously disabled software functionality to display SpO2 information from cleared OEM Masimo pulse oximetry accessories and sensors. The radiant heating element, irradiance specifications (10–32 mW/cm² at 30–100% power), warming modes (manual, skin temperature, kangaroo), and all other features remain identical to the predicate K230278. A new SpO2 alarm-setting feature is added via the GUI.

IEC 60601-1 (electrical, thermal, mechanical safety); IEC 60601-1-2 (electromagnetic compatibility); IEC 62304 (software lifecycle); ISO 80601-2-61:2017 (pulse oximeter requirements); FDA guidance on device software functions (June 2023) and cybersecurity (September 2023); OEM integration validation testing using clinical simulator.

The subject device has identical intended use, indications, and all core warming components as predicate K230278. The sole modification is activation of existing software to display SpO2 data from cleared accessories—this does not change the device's fundamental operation or safety profile. Verification testing confirms SpO2 signal integrity and compliance with pulse oximetry standards ISO 80601-2-61:2017, and cybersecurity assessment addresses the new external SpO2 interface, demonstrating that adding this optional display feature does not create new risks or alter substantial equivalence.