# K213488: Bladder Scanner, Model Name:M5

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou Peaksonic Medical Technology Co., Ltd.
- Decided: Jul 1, 2022 after 242 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: 12 generations back to K935595 (1995). 103 ancestors in all.
No later device cites it as a predicate yet.
0 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172750: Wireless Probe Type Ultrasound Scanner (Model:UProbe-C; UProbe-L; BProbe), Guangzhou Sonostar Technologies Co., Ltd. (2018) Summary page 4.

## Indications for use
The Bladder Scanner (ModelName:M5) is intended to project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease. Mode of operation: B-mode. Intended user population:Trained and qualified healthcare professionals. Intended use environment:Professional health care facilities.

Source page: https://510kreport.com/device/K213488
Methodology: https://510kreport.com/methodology