510(k) · Cleared
ClearedBladdermanager Pci 5000 / Bladderscan Bvi 5000
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 May 24, 1996 as substantially equivalent to K915436 (Diagnostic Ultrasound Corp., 1992) after a 150-day review. Its family tree reaches back 1 generation to 1992. 49 later devices descend from it.
- Decided
- May 24, 1996
- Review
- 150 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915436 (1992). 49 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- This deviceK955840 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
- Descendant · 4 generations on · 7 of its ownK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 49 · See all- 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
- K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| 0 (this device) | 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 | — |
| +4 | K131227 | Padscan HD Series Bladder Scanner | Carenoso Technology Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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), 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 |
|---|---|---|---|
| * | K915436 | Bladderscan Bvi 2500Summary page 1…nic Bladder Volume Instrument Classification Name System, Imaging, Pulsed Echo, Ultrasonic Predicate Device Diagnostic Ultrasound Corporation’s BladderScan™ BVI 2500 (K 915436) Corporate Headquarters Canadian Office European Office b Yottt dreet 13500 Mayrest W, st 10 Lagedijk 14 ! TOWA BN Richmond, BC… | 1992 |
What descends from it? (49)
See all 492 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?
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 | — |
What is it indicated for?
project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume 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/K955840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955840: Bladdermanager Pci 5000 / Bladderscan Bvi 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955840
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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