# K172356: BladderScan Prime PLUS System

- Pathway: 510(k) (Traditional)
- Applicant: Verathon Incorporated
- Decided: Sep 15, 2017 after 43 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K915436 (1992). 7 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K153101: BladderScan Prime System, Verathon Incorporated (2015) Summary page 4.

## Most influential descendants
- 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

## Recalls of this device
- Sep 29, 2020 · Class II · Z-0531-2021: Due to a change in handle material and process, probe handle may crack.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K172356
Methodology: https://510kreport.com/methodology