# K090214: Verathon Inc. Bladderscan BVM 9500 Ultrasound

- Pathway: 510(k) (Abbreviated)
- Applicant: Verathon Incorporated
- Decided: Mar 13, 2009 after 43 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: 4 generations back to K915436 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 2.
- K030763: Diagnostic Ultrasound Bladdermass BVM 6500 Ultrasound System, Diagnostic Ultrasound Corp. (2003) Summary page 1.

## Recalls of this device
- Aug 23, 2010 · Not classified · Z-0005-2011: The BladderScan BVM 9500 devices may experience the loss of a factory installed software configuration file which results in a loss of the aorta measurement function.

## Indications for use
The BladderScan® BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass non-invasively.

Source page: https://510kreport.com/device/K090214
Methodology: https://510kreport.com/methodology