# K153101: BladderScan Prime System

- Pathway: 510(k) (Traditional)
- Applicant: Verathon Incorporated
- Decided: Nov 19, 2015 after 24 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: 4 generations back to K915436 (1992). 6 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071217: Bladderscan Bvi 9400 Ultrasound, Verathon Incorporated (2007) Summary page 7.

## Most influential descendants
- K172356: BladderScan Prime PLUS System (2017), 3 descendants of its own
- K231677: EdgeFlow UH10 (2024), 1 descendant of its own
- K252237: EdgeFlow UW20 (2026), 0 descendants of its own
- K200980: Auto 3D Bladder Volume Tool (2020), 0 descendants of its own

## Indications for use
The BladderScan® Prime system is an ultrasound device intended to be used for measuring the urine volume in the bladder non-invasively.

Source page: https://510kreport.com/device/K153101
Methodology: https://510kreport.com/methodology