# K030763: Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Ultrasound Corp.
- Decided: Mar 26, 2003 after 15 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915436 (1992). 5 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022153: Bladderscan Bvi 6100, Diagnostic Ultrasound Corp. (2002)

## Most influential descendants
- K083534: Lifebed Network Patient Vigilance System (2009), 2 descendants of its own
- K100745: Lifebed Network Patient Vigilance System (2010), 0 descendants of its own
- K092037: Lifegurney Network Patient Vigilance System (2009), 0 descendants of its own
- K090214: Verathon Inc. Bladderscan BVM 9500 Ultrasound (2009), 0 descendants of its own

## Recalls of this device
- Sep 20, 2010 · Not classified · Z-0143-2011: 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 Q

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body

Source page: https://510kreport.com/device/K030763
Methodology: https://510kreport.com/methodology