# K200980: Auto 3D Bladder Volume Tool

- Pathway: 510(k) (Traditional)
- Applicant: Butterfly Network, Inc.
- Decided: Jun 11, 2020 after 58 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K915436 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172356: BladderScan Prime PLUS System, Verathon Incorporated (2017) Summary page 5.

## Indications for use
The Butterfly Auto 3D Bladder Volume Tool is a software application package. It is designed to view, quantify and report results acquired on Butterfly Network ultrasound systems for noninvasive volume measurements of the bladder, to support physician diagnosis. Indicated for use in adult populations.

Source page: https://510kreport.com/device/K200980
Methodology: https://510kreport.com/methodology