# K201995: CUBEScan BioCon-1100

- Pathway: 510(k) (Special)
- Applicant: Mcube Technology Co., Ltd.
- Decided: Aug 19, 2020 after 30 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 4.

## Indications for use
The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use and use on pregnant patients.

Source page: https://510kreport.com/device/K201995
Methodology: https://510kreport.com/methodology