510(k) · Cleared
Recalled · 2010Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System
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 26, 2003 as substantially equivalent to K022153 (Diagnostic Ultrasound Corp., 2002) after a 15-day review. Its family tree reaches back 3 generations to 1992. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 26, 2003
- 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. 4 later devices descend from it, 3 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 deviceK030763 Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound SystemDiagnostic Ultrasound Corp. · 2003
- Descendant · cites it directly · 2 of its ownK083534 Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK100745 Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK092037 Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK090214 Verathon Inc. Bladderscan BVM 9500 UltrasoundVerathon Incorporated · 2009 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K083534Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2009 · cites it directly2descendants
- K100745Lifebed Network Patient Vigilance SystemHoana Medical, Inc. · 2010 · cites it directly0descendants
- K092037Lifegurney Network Patient Vigilance SystemHoana Medical, Inc. · 2009 · 2 generations on0descendants
- K090214Verathon Inc. Bladderscan BVM 9500 UltrasoundVerathon Incorporated · 2009 · cites it directly0descendants
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) | K030763 | Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System | Diagnostic Ultrasound Corp. | 2003 | — |
| +1 | K083534 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | 2009 | — |
| +1 | K100745 | Lifebed Network Patient Vigilance System | Hoana Medical, Inc. | 2010 | — |
| +2 | K092037 | Lifegurney Network Patient Vigilance System | Hoana Medical, Inc. | 2009 | — |
| +1 | K090214 | Verathon Inc. Bladderscan BVM 9500 Ultrasound | Verathon Incorporated | 2009 | 1 |
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 |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K022153 | Bladderscan Bvi 6100 | 2002 |
What descends from it? (4)
3 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 11 years and passes through 1 company; a new generation was cleared every 4.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K083534 (Hoana Medical, Inc., 2009) has gone furthest, with 2 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.
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?
Diagnostic ultrasound imaging or fluid flow analysis of the human body
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030763 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030763: Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030763
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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