# K982568: Bladdermanager Pci 5000 Model 1002

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Ultrasound Corp.
- Decided: Jan 25, 1999 after 186 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915436 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955840: Bladdermanager Pci 5000 / Bladderscan Bvi 5000, Diagnostic Ultrasound Corp. (1996) Summary page 1.

## Indications for use
The BladderManager® PCl 5000(+) is intended to project ultrasound energy through the lower abdomen of the non-pregnant in order to obtain an image of the bladder that is used to determine bladder volume non-invasively. This capability is provided in 2 fundamental modes; 1) hand held probe, aimed by user to obtain reading and 2) Automatically monitor bladder volume via a garment-held probe on non-mobile, supine patient. Patients and/or caregivers are alerted visually and/or audibly when the bladder volume exceeds a pre-programmed threshold.

Source page: https://510kreport.com/device/K982568
Methodology: https://510kreport.com/methodology