Cleared Traditional

K200980 - Auto 3D Bladder Volume Tool (FDA 510(k) Clearance)

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

K200980 · Butterfly Network, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Jun 2020
Decision
58d
Days
Class 2
Risk

K200980 is an FDA 510(k) clearance for the Auto 3D Bladder Volume Tool. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Butterfly Network, Inc. (Guildford, US). The FDA issued a Cleared decision on June 11, 2020 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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 K200980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2020
Decision Date June 11, 2020
Days to Decision 58 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 107d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 Peers - IYO System, Imaging, Pulsed Echo, Ultrasonic

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