FDA 510(k)

Butterfly Gestational Age Tool

K-Number: K252148 · 2026-03-27

Decision Date2026-03-27

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Butterfly Gestational Age Tool is the device name listed in this FDA 510(k) record. The listed applicant is Butterfly Network, Inc.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) 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. The listed applicant is Butterfly Network, Inc.. The 510(k) number is K252148.

When did Butterfly Gestational Age Tool receive FDA 510(k) clearance?

Butterfly Gestational Age Tool received FDA 510(k) clearance on 2026-03-27, under 510(k) number K252148.

Who is the listed applicant for Butterfly Gestational Age Tool?

The FDA 510(k) record lists Butterfly Network, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Butterfly Gestational Age Tool?

The FDA product code for Butterfly Gestational Age Tool is IYN.

Other records listing Butterfly Network, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: IYN)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.