510(k) · Cleared
Recalled · 2009Bladderscan Bvi 9400 Ultrasound
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 May 17, 2007 as substantially equivalent to K022153 (Diagnostic Ultrasound Corp., 2002) after a 15-day review. Its family tree reaches back 3 generations to 1992. 45 later devices descend from it. It has been recalled once.
- Decided
- May 17, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915436 (1992). 5 ancestors in all. 45 later devices descend from it, 12 citing it directly.
- Root · 3 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 2 generations backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- 1 generation backK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002 · Recalled
- This deviceK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007
- Descendant · cites it directly · 16 of its ownK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
- Descendant · cites it directly · 13 of its ownK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
- Descendant · 2 generations on · 7 of its ownK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
- Descendant · cites it directly · 7 of its ownK130229 Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK132736 Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009 · cites it directly16descendants
- K111021Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011 · cites it directly13descendants
- K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013 · 2 generations on7descendants
- K130229Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 2013 · cites it directly7descendants
- K132736Accuro 3000 Ultrasound ScannerRivanna Medical, LLC · 2014 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −2 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| −1 | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | 1 |
| 0 (this device) | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | — |
| +1 | K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | Mcube Technology Co., Ltd. | 2009 | — |
| +1 | K111021 | Cubescan / Biocon-700 | Mcube Technology Co., Ltd. | 2011 | — |
| +2 | K131227 | Padscan HD Series Bladder Scanner | Carenoso Technology Co., Ltd. | 2013 | — |
| +1 | K130229 | Palm Bladder Scanner | Mianyang Meike Electronic Equipment Co., Ltd. | 2013 | — |
| +1 | K132736 | Accuro 3000 Ultrasound Scanner | Rivanna Medical, LLC | 2014 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K022153 | Bladderscan Bvi 6100Summary page 1…· Product Code 90-ITX Predicate Device: Verathon BladderScan® BVI 6100 Ultrasound System (K022153) 33 Device Descri… | 2002 |
What descends from it? (45)
See all 4512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | 2009 | 16 |
| K111021 | Cubescan / Biocon-700 | 2011 | 13 |
| K130229 | Palm Bladder Scanner | 2013 | 7 |
| K132736 | Accuro 3000 Ultrasound Scanner | 2014 | 5 |
| K153101 | BladderScan Prime System | 2015 | 4 |
| K083534 | Lifebed Network Patient Vigilance System | 2009 | 2 |
| K160420 | SpeqT | 2016 | 1 |
| K170046 | Lilium a-200E | 2017 | 0 |
| K121689 | Vitascan LT Scanmaster | 2012 | 0 |
| K100745 | Lifebed Network Patient Vigilance System | 2010 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 18, 2009 | Not classified | Z-1939-2009 | Software design | Three specific issues are being addressed: 1. Calculation and use of an incorrect year in dates after 12/31/2009. 2. Double scans, continuous scans, and double printing. 3. Calibration sensitivity. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K091518 (Mcube Technology Co., Ltd., 2009) has gone furthest, with 16 descendants of its own.
- 2 other devices also cite its predicate K022153.
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. 2007, 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?
* Abdomen, B-Mode, per Indications for Use Ultrasound Form
* The BladderScan® BVI 9400 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume and bladder wall mass noninvasively.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071217: Bladderscan Bvi 9400 Ultrasound.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071217
Report an extraction error
Are you the manufacturer?
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