Data / Medical devices / United States / Butterfly Network, Inc.

Butterfly Network, Inc.: FDA-registered device maker in Burlington, MA, United States, 6 510(k) clearances

Name: Butterfly Network, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Butterfly Network, Inc. is registered with the FDA (registration 3010102386) in Burlington, MA, United States. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated March 27, 2026. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010102386
Address: 1600 District Ave, Burlington, MA, United States, 01803
Owner or operator: Butterfly Network, Inc. (10057531)
Roles: Manufacturer, Specification developer
First device listed: April 19, 2018
Registered through: 2026
Brand names listed: Auto 3D Bladder Volume Tool, Butterfly Gestational Age Tool, Butterfly iQ, Butterfly iQ Ultrasound System, Butterfly iQ+, Butterfly iQ+ Ultrasound System, Butterfly iQ/iQ+ Ultrasound System, Butterfly iQ3 Ultrasound System

Devices it lists

Device	Product code	Class	Role	Source
Automated Radiological Image Processing Software	QIH	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 27, 2026	K252148	Butterfly Gestational Age Tool	IYN	Substantially Equivalent	Butterfly Network, Inc.	accessdata.fda.gov
January 4, 2024	K232808	Butterfly iQ3 Ultrasound System	IYN	Substantially Equivalent	Butterfly Network, Inc.	accessdata.fda.gov
March 31, 2023	K220068	Butterfly iQ/iQ+ Ultrasound System	IYO	Substantially Equivalent	Butterfly Network, Inc.	accessdata.fda.gov
September 16, 2020	K202406	Butterfly iQ Ultrasound System	IYN	Substantially Equivalent	Butterfly Network, Inc.	accessdata.fda.gov
June 11, 2020	K200980	Auto 3D Bladder Volume Tool	IYO	Substantially Equivalent	Butterfly Network, Inc.	accessdata.fda.gov
September 6, 2017	K163510	Poseidon Ultrasound System	IYN	Substantially Equivalent	Butterfly Network, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 24, 2020	85185	Class II	Terminated	Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool REF/Model: 850-20003 Software versions 1.13.0, 1.14.0, and 1.15.0 - Product Usage: Butterfly iQ is i	Distributed without an approved 510(k)	accessdata.fda.gov
February 24, 2020	85178	Class II	Terminated	Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)00866646000206 Software versions 1.10.0, 1.11.0, 1.12.0, 1.13.0, 1.13.0, 1.14.0, 1.15.0 Product Usage: Intended	Distributed without an approved 510(k)	accessdata.fda.gov

Compare with other makers

Updated March 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.