Butterfly Gestational Age Tool
K-Number: K252148 · 2026-03-27
ApplicantButterfly Network, Inc.
Decision Date2026-03-27
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Butterfly Gestational Age Tool is a medical device manufactured by Butterfly Network, Inc.. It received FDA 510(k) clearance on 2026-03-27 under approval number K252148. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Butterfly Gestational Age Tool?
Butterfly Gestational Age Tool is a medical device that received FDA 510(k) clearance on 2026-03-27. It is manufactured by Butterfly Network, Inc.. The 510(k) number is K252148.
When was Butterfly Gestational Age Tool approved by the FDA?
Butterfly Gestational Age Tool received FDA 510(k) clearance on 2026-03-27, under approval number K252148.
What company makes Butterfly Gestational Age Tool?
Butterfly Gestational Age Tool is manufactured by Butterfly Network, Inc..
What is the FDA product code for Butterfly Gestational Age Tool?
The FDA product code for Butterfly Gestational Age Tool is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.