510(k) · Cleared
ClearedBladderScan Prime System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verathon Incorporated · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Nov 19, 2015 as substantially equivalent to K071217 (Verathon Incorporated, 2007) after a 24-day review. Its family tree reaches back 4 generations to 1992. 4 later devices descend from it.
- Decided
- Nov 19, 2015
- Review
- 24 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915436 (1992). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 3 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 2 generations backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- 1 generation backK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- This deviceK153101 BladderScan Prime SystemVerathon Incorporated · 2015
- Descendant · cites it directly · 3 of its ownK172356 BladderScan Prime PLUS SystemVerathon Incorporated · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK231677 EdgeFlow UH10Edgecare, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK252237 EdgeFlow UW20Edgecare, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK200980 Auto 3D Bladder Volume ToolButterfly Network, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K172356BladderScan Prime PLUS SystemVerathon Incorporated · 2017 · cites it directly3descendants
- K231677EdgeFlow UH10Edgecare, Inc. · 2024 · 2 generations on1descendant
- K252237EdgeFlow UW20Edgecare, Inc. · 2026 · 3 generations on0descendants
- K200980Auto 3D Bladder Volume ToolButterfly Network, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −3 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −2 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| −1 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| 0 (this device) | K153101 | BladderScan Prime System | Verathon Incorporated | 2015 | — |
| +1 | K172356 | BladderScan Prime PLUS System | Verathon Incorporated | 2017 | 1 |
| +2 | K231677 | EdgeFlow UH10 | Edgecare, Inc. | 2024 | — |
| +3 | K252237 | EdgeFlow UW20 | Edgecare, Inc. | 2026 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K071217 | Bladderscan Bvi 9400 UltrasoundSummary page 7…A1-0003 3. Identification of the predicate or legally marketed device: BladderScan® BVI 9400 K071217 4. Device Description: The BladderScan® Prime system instrument provides noninvasive measurement of urinary blad… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172356 | BladderScan Prime PLUS System | 2017 | 3 |
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 23 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K172356 (Verathon Incorporated, 2017) has gone furthest, with 3 descendants of its own.
- 11 other devices also cite its predicate K071217.
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. 2015, 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 BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine volume in the bladder non-invasively.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153101 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153101: BladderScan Prime System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153101
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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