# K260313: MD-6000S Bladder Scanner

- Pathway: 510(k) (Traditional)
- Applicant: MEDA Co., Ltd.
- Decided: Sep 24, 2026 after 237 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: 8 generations back to K915436 (1992). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200548: CUBEScan BioCon-1100, Mcube Technology Co., Ltd. (2020) Summary page 5.

## Indications for use
MD-6000S Bladder Scanner is a B-mode pulsed-echo ultrasound device. It is intended to measure the volume of bladder. The device is intended to be used in medical and nursing care institutions. It should be used by appropriately trained and qualified healthcare professionals.

Source page: https://510kreport.com/device/K260313
Methodology: https://510kreport.com/methodology