# K182460: MD-6000P Bladder Scanner

- Pathway: 510(k) (Traditional)
- Applicant: MEDA Co., Ltd.
- Decided: May 6, 2019 after 238 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: 6 generations back to K915436 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113304: Bladder Scanner, MEDA Co., Ltd. (2012) Summary page 5.

## Indications for use
MD-6000P Bladder Scanner is intended to measure the urine volume in human bladder. The device is intended to be used in medical and nursing care institutions. It should be operated by trained professionals. The device is not intended for use on pregnant women. It cannot be used on wounded skin.

Source page: https://510kreport.com/device/K182460
Methodology: https://510kreport.com/methodology