510(k) · Cleared
ClearedAuto 3D Bladder Volume Tool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Butterfly Network, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Jun 11, 2020 as substantially equivalent to K172356 (Verathon Incorporated, 2017) after a 58-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Jun 11, 2020
- Review
- 58 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K915436 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 5 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 4 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- 3 generations backK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- 2 generations backK153101 BladderScan Prime SystemVerathon Incorporated · 2015
- 1 generation backK172356 BladderScan Prime PLUS SystemVerathon Incorporated · 2017 · Recalled
- This deviceK200980 Auto 3D Bladder Volume ToolButterfly Network, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −5 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −4 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| −3 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| −2 | K153101 | BladderScan Prime System | Verathon Incorporated | 2015 | — |
| −1 | K172356 | BladderScan Prime PLUS System | Verathon Incorporated | 2017 | 1 |
| 0 (this device) | K200980 | Auto 3D Bladder Volume Tool | Butterfly Network, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K172356 | BladderScan Prime PLUS SystemSummary page 5…21 CFR 892.1570 ITX Classification Class II Butterfly Network, Inc. 1 Predicate Device: K172356 – BladderScan Prime PLUS System, Verathon, Inc. (Clearance Date: 09/15/2017) Device Summary: The Butterfly Auto 3D Bladder… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 1 other device also cites its predicate K172356.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200980 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200980: Auto 3D Bladder Volume Tool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200980
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026