510(k) · Cleared
ClearedBladderscan Bvi 2500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Ultrasound Corp. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on Mar 3, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 51 later devices descend from it.
- Decided
- Mar 3, 1992
- Review
- 90 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 0
51 later devices descend from it, 3 citing it directly.
- This deviceK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- Descendant · cites it directly · 49 of its ownK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- Descendant · cites it directly · 47 of its ownK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- Descendant · 2 generations on · 45 of its ownK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- Descendant · 3 generations on · 16 of its ownK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
- Descendant · 3 generations on · 13 of its ownK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K955840Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996 · cites it directly49descendants
- K022153Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · cites it directly47descendants
- K071217Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · 2 generations on45descendants
- K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009 · 3 generations on16descendants
- K111021Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011 · 3 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| +1 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| +1 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| +2 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| +3 | K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | Mcube Technology Co., Ltd. | 2009 | — |
| +3 | K111021 | Cubescan / Biocon-700 | Mcube Technology Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (51)
See all 513 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K955840 (Diagnostic Ultrasound Corp., 1996) has gone furthest, with 49 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K915436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K915436: Bladderscan Bvi 2500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K915436
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026