Cleared Traditional

Butterfly iQ Ultrasound System (K202406) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K202406 · Butterfly Network, Inc. · Radiology device
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Sep 2020
Decision
26d
Days
Class 2
Risk

K202406 is an FDA 510(k) clearance for the Butterfly iQ Ultrasound System. Classified as System, Imaging, Pulsed Doppler, Ultrasonic within the IYN classification (a category covering pulsed Doppler and ultrasound imaging systems), Class II - Special Controls.

Submitted by Butterfly Network, Inc. (Guildford, US). The FDA issued a Cleared decision on September 16, 2020 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1550 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Butterfly Network, Inc. devices

Submission Details

510(k) Number K202406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2020
Decision Date September 16, 2020
Days to Decision 26 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 107d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code IYN System, Imaging, Pulsed Doppler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYN System, Imaging, Pulsed Doppler, Ultrasonic

All 631
Devices cleared under the same product code (IYN) and FDA review panel - the closest regulatory comparables to K202406.
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System
K202683 · Siemens Medical Solutions USA, Inc. · Oct 2020
Voluson SWIFT, Voluson SWIFT+
K201828 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Oct 2020
Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1
K201972 · Canon Medical Systems Corporation · Oct 2020
Vivid iq
K200708 · Ge Medical Systems Ultrasound And · Sep 2020
Vivid T8, Vivid T9
K200851 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 2020
EPIQ Series Diagnostic Ultrasound Systems
K202216 · Philips Ultrasound, Inc. · Sep 2020