# K071217: Bladderscan Bvi 9400 Ultrasound

- Pathway: 510(k) (Traditional)
- Applicant: Verathon Incorporated
- Decided: May 17, 2007 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.
45 later devices descend from it; 12 cite it directly.
0 of 51 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) Summary page 1.

## Most influential descendants
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System (2009), 16 descendants of its own
- K111021: Cubescan / Biocon-700 (2011), 13 descendants of its own
- K131227: Padscan HD Series Bladder Scanner (2013), 7 descendants of its own
- K130229: Palm Bladder Scanner (2013), 7 descendants of its own
- K132736: Accuro 3000 Ultrasound Scanner (2014), 5 descendants of its own

## Recalls of this device
- May 18, 2009 · Not classified · Z-1939-2009: 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.

## Indications for use
* 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:

Source page: https://510kreport.com/device/K071217
Methodology: https://510kreport.com/methodology