# K955840: Bladdermanager Pci 5000 / Bladderscan Bvi 5000

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Ultrasound Corp.
- Decided: May 24, 1996 after 150 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K915436 (1992). 1 ancestor in all.
49 later devices descend from it; 2 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)
- K915436: Bladderscan Bvi 2500, Diagnostic Ultrasound Corp. (1992) Summary page 1.

## Most influential descendants
- K022153: Bladderscan Bvi 6100 (2002), 47 descendants of its own
- K071217: Bladderscan Bvi 9400 Ultrasound (2007), 45 descendants of its own
- 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

## Indications for use
project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively.

Source page: https://510kreport.com/device/K955840
Methodology: https://510kreport.com/methodology