Chrysalis Intelligence · Sponsors · Butterfly Network, Inc.

Butterfly Network, Inc.

Burlington, MA, US · 5 510(k) clearances · 2 recalls

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Total clearances
5
2020-06-11 → 2026-03-27
Last 12 months
1
Product codes
2
Most recent
2026-03-27
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
IYN System, Imaging, Pulsed Doppler, Ultrasonic Class II Radiology 3 2026-03-27
IYO System, Imaging, Pulsed Echo, Ultrasonic Class II Radiology 2 2023-03-31
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
0
Most recent
2020-02-24
DateSeverityStatusRecall # ProductCodeReason
2020-02-24 Class II Terminated Z-1601-2020 Butterfly iQ Ultrasound System containing the Auto EF(Ejection Fraction) Tool REF/Model: 850-20003 UDI: (01)0086664600… — Distributed without an approved 510(k)
2020-02-24 Class II Terminated Z-1600-2020 Butterfly iQ Ultrasound System Auto Bladder Volume Tool-The Auto Bladder Volume Tool is a segmentation measurement tool … — Distributed without an approved 510(k)
Filings

All 510(k) clearances (5)

Date K-number Device Code Class Specialty
2026-03-27 K252148 Butterfly Gestational Age Tool IYN Class II Radiology
2024-01-04 K232808 Butterfly iQ3 Ultrasound System IYN Class II Radiology
2023-03-31 K220068 Butterfly iQ/iQ+ Ultrasound System IYO Class II Radiology
2020-09-16 K202406 Butterfly iQ Ultrasound System IYN Class II Radiology
2020-06-11 K200980 Auto 3D Bladder Volume Tool IYO Class II Radiology
Data source: openFDA · Generated 2026-07-25 22:26 · Last ingest 2026-07-25T13:19:55.737268 · Pipeline: Chrysalis Intelligence