# K963585: Bladder Manager Pci 5000, Bladderscan Bvi 5000

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Ultrasound Corp.
- Decided: Oct 1, 1996 after 22 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 K881731 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881731: AD-Heal (TM) Wound Dressing, Nepera, Inc. (1988) Summary page 2.

## Indications for use
The BladderManager PCI 5000 and BladderScan BVI 5000 “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/K963585
Methodology: https://510kreport.com/methodology