510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Butterfly Network, Inc.

Burlington, MA, US

BUTTERFLY NETWORK, INC. appears in FDA device records in Burlington, MA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Butterfly Network, Inc. between 2017 and 2026. The busiest year on record is 2020, with 2. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Butterfly Network, Inc., by decision year
YearClearances
20171
20202
20231
20241
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K252148Butterfly Gestational Age ToolIYNSubstantially Equivalent
K232808Butterfly iQ3 Ultrasound SystemIYNSubstantially Equivalent
K220068Butterfly iQ/iQ+ Ultrasound SystemIYOSubstantially Equivalent
K202406Butterfly iQ Ultrasound SystemIYNSubstantially Equivalent
K200980Auto 3D Bladder Volume ToolIYOSubstantially Equivalent
K163510Poseidon Ultrasound SystemIYNSubstantially Equivalent

Registered establishments

FDA registered establishments for Butterfly Network, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30101023863010102386BUTTERFLY NETWORK, INC.1600 District Ave, Burlington, MA 01803 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1600-2020Butterfly 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 indicated for use by qualified and trained healthcare professionals to enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients.Distributed without an approved 510(k)Class IITerminated
Z-1601-2020Butterfly 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 use: Diagnostic ultrasound imaging and measurement of anatomical structures.Distributed without an approved 510(k)Class IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain