# K113304: Bladder Scanner

- Pathway: 510(k) (Traditional)
- Applicant: MEDA Co., Ltd.
- Decided: Mar 23, 2012 after 136 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: 5 generations back to K915436 (1992). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091518: Cubescan Biocon-500 Diagnostic Ultrasound System, Mcube Technology Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K182460: MD-6000P Bladder Scanner (2019), 0 descendants of its own

## Indications for use
MD-6000 Bladder Scanner is a portable battery-operated ultrasonic equipment of pulse reflection. It is intended to measure the volume of bladder filled with urine. The MD-6000 is intended to be used only by qualified medical professionals. Contraindications for the MD-6000 are fetal use and use on pregnant patients.

Source page: https://510kreport.com/device/K113304
Methodology: https://510kreport.com/methodology