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The Tracker / March 2026 / K252148

510(k) cleared

Butterfly Gestational Age Tool

Butterfly Network, Inc. · Mar 27, 2026 · K252148

FDA cleared the Butterfly Gestational Age Tool from Butterfly Network, Inc. on Mar 27, 2026 under K252148, a traditional 510(k). The device falls under product code IYN, System, Imaging, Pulsed Doppler, Ultrasonic, regulated at 21 CFR 892.1550 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 9, 2025. The decision came 261 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Butterfly Network, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252148?

K252148 is the FDA 510(k) for Butterfly Gestational Age Tool, submitted by Butterfly Network, Inc.. FDA's decision date was Mar 27, 2026, under product code IYN (System, Imaging, Pulsed Doppler, Ultrasonic).

Who makes the Butterfly Gestational Age Tool?

Butterfly Network, Inc., based in Burlington, MA, is the applicant of record for K252148.

How long did the K252148 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Mar 27, 2026, 261 days later.

← All decisions in March 2026