510(k) · Cleared
Recalled · 2010Bladderscan Bvi 6100
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 Aug 15, 2002 as substantially equivalent to K955840 (Diagnostic Ultrasound Corp., 1996) and 2 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1992. 47 later devices descend from it. It has been recalled once.
- Decided
- Aug 15, 2002
- Review
- 44 days
- Class
- Class II
- Product code
- IYO
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K915436 (1992). 4 ancestors in all. 47 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK915436 Bladderscan Bvi 2500Diagnostic Ultrasound Corp. · 1992
- 1 generation backK955840 Bladdermanager Pci 5000 / Bladderscan Bvi 5000Diagnostic Ultrasound Corp. · 1996
- This deviceK022153 Bladderscan Bvi 6100Diagnostic Ultrasound Corp. · 2002
- Descendant · cites it directly · 45 of its ownK071217 Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · Recalled
- Descendant · 2 generations on · 16 of its ownK091518 Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009
- Descendant · 2 generations on · 13 of its ownK111021 Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011
- Descendant · 3 generations on · 7 of its ownK131227 Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013
- Descendant · 2 generations on · 7 of its ownK130229 Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 2013
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K071217Bladderscan Bvi 9400 UltrasoundVerathon Incorporated · 2007 · cites it directly45descendants
- K091518Cubescan Biocon-500 Diagnostic Ultrasound SystemMcube Technology Co., Ltd. · 2009 · 2 generations on16descendants
- K111021Cubescan / Biocon-700Mcube Technology Co., Ltd. · 2011 · 2 generations on13descendants
- K131227Padscan HD Series Bladder ScannerCarenoso Technology Co., Ltd. · 2013 · 3 generations on7descendants
- K130229Palm Bladder ScannerMianyang Meike Electronic Equipment Co., Ltd. · 2013 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915436 | Bladderscan Bvi 2500 | Diagnostic Ultrasound Corp. | 1992 | — |
| −1 | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 | Diagnostic Ultrasound Corp. | 1996 | — |
| 0 (this device) | K022153 | Bladderscan Bvi 6100 | Diagnostic Ultrasound Corp. | 2002 | — |
| +1 | K071217 | Bladderscan Bvi 9400 Ultrasound | Verathon Incorporated | 2007 | 1 |
| +2 | K091518 | Cubescan Biocon-500 Diagnostic Ultrasound System | Mcube Technology Co., Ltd. | 2009 | — |
| +2 | K111021 | Cubescan / Biocon-700 | Mcube Technology Co., Ltd. | 2011 | — |
| +3 | K131227 | Padscan HD Series Bladder Scanner | Carenoso Technology Co., Ltd. | 2013 | — |
| +2 | K130229 | Palm Bladder Scanner | Mianyang Meike Electronic Equipment Co., Ltd. | 2013 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K955840 | Bladdermanager Pci 5000 / Bladderscan Bvi 5000 Our reading of the summary gave K955850, FDA’s number for Pro-Tech (Central Solutions, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Diagnostic Ultrasound BladderManager BVI 5000 System”. | 1996 |
| * | K915436 | Bladderscan Bvi 2500Summary page 2…equivalent to the previously cleared Diagnostic Ultrasound BladderManagerTMBVI 5000 System (K955850), Diagnostic Ultrasound BladderScanTMBVI 2500 System (K915436), and the SonoSiteTMHand- Carried Ultrasound System (K990806). Device Description: The BladderScanTMBVI 6100 Ultrasound Syste… | 1992 |
| * | K990806 | C1 Ultrasound SystemSummary page 2…Ultrasound BladderManagerTMBVI 5000 System (K955850), Diagnostic Ultrasound BladderScanTMBVI 2500 System (K915436), and the SonoSiteTMHand- Carried Ultrasound System (K990806). Device Description: The BladderScanTMBVI 6100 Ultrasound System is a hand-held, battery- powered, software-controlled ultra… | 1999 |
What descends from it? (47)
See all 473 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2010 | Not classified | Z-0143-2011 | Software design (manufacturing process) | Incorrect programming causes QuickPrint to fail to recognize the communication Cradles. As a result, ScanPoint Communications Cradles could not communicate with ScanPoint Online Tool while using the QuickPrint interface. This will affect… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 6.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K071217 (Verathon Incorporated, 2007) has gone furthest, with 45 descendants of its own.
- 1 other device also cites its predicate K955840.
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?
The BVI 6100 System is intended to project ultrasound energy through the lower abdomen of a nonpregnant patient to obtain an image of the bladder and measure urinary bladder volume non-invasively on an intermittent basis. The indications for use are the same as for Diagnostic Ultrasound’s predicate devices. The Bladderscan BVI 6100 is contraindicated for fetal use and for use on pregnant patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022153 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022153: Bladderscan Bvi 6100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022153
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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