Bladder Manager PCI 5000, BladderScan BVI 5000

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K963585 ↗

FDA Product Code

IYO

Device Class

Class II

Regulation

21 CFR Part 892.1560

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Bladdermanager Pci 5000 Model 1002

  Class II

  FDA 510(k) K982568 Active Cleared 25 Jan 1999

• Diagnostic Ultrasound/Uro-Gyn Ud 511

  Class II

  FDA 510(k) K911166 Active Cleared 15 Aug 1991

• Diagnostic Ultrasound 105 & 110

  Class II

  FDA 510(k) K842539 Active Cleared 10 Apr 1985

• Bladderscan Bvi 5000

  Class II

  FDA 510(k) K955942 Active Cleared 15 Mar 1996

• Diagnostic Ultrasound/Uro-Gyn Ups 2020

  Class II

  FDA 510(k) K911125 Active Cleared 15 Aug 1991

• Diagnostic Ultrasound/Uro-GYN UDS 1002

  Class II

  FDA 510(k) K902692 Active Cleared 13 Sep 1990

See all devices from Diagnostic Ultrasound Corp. →

• What is the Bladder Manager PCI 5000 and BladderScan BVI 5000 used for?

  These devices are portable, battery-powered pulsed echo ultrasound instruments designed for non-invasive bladder volume measurement. They project ultrasound energy through the lower abdomen to obtain bladder images and calculate volume using acoustic coupling via a hydrogel gel pad, intended for intermittent monitoring in clinical or home settings.

• How are the Bladder Manager PCI 5000 and BladderScan BVI 5000 supplied and what are their key differences?

  Both devices are supplied as non-sterile, reusable ultrasound instruments with hydrogel gel pads as single-use accessories. The BladderScan BVI 5000 is intended for clinician use and includes a docking cradle with onboard computer for hard copy printouts of images and volume measurements, while the Bladder Manager PCI 5000 is designed for patient self-use.

• Are the hydrogel gel pads for these devices sterile or single-use?

  The hydrogel gel pads are supplied as single-use accessories and are not sterile. The devices themselves are non-sterile and reusable, but the gel pads must be replaced after each use to ensure proper acoustic coupling and hygiene.