510(k) K252148

Butterfly Gestational Age Tool by Butterfly Network, Inc. — Product Code IYN

K252148 is an FDA 510(k) premarket notification submitted by Butterfly Network, Inc. for the device "Butterfly Gestational Age Tool". The FDA issued a decision of Substantially Equivalent on March 27, 2026. The device falls under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic), a Class II device regulated under 21 CFR 892.1550. Butterfly Network, Inc. has at least 5 other 510(k) clearances on record.