# K142329: BBS Revolution

- Pathway: 510(k) (Abbreviated)
- Applicant: Dbmedx, Inc.
- Decided: Dec 15, 2014 after 117 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The BBS Revolution system projects ultrasound energy through the lower abdomen of the patient to obtain an image of the bladder, which is used to calculate bladder volume non-invasively.

Source page: https://510kreport.com/device/K142329
Methodology: https://510kreport.com/methodology