# K131227: Padscan HD Series Bladder Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Carenoso Technology Co., Ltd.
- Decided: Jul 12, 2013 after 73 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.
7 later devices descend from it; 4 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111021: Cubescan / Biocon-700, Mcube Technology Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K190769: Bladder Scanner (Models: M2, M2-W, M1, M1-W) (2019), 3 descendants of its own
- K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) (2021), 2 descendants of its own
- K250331: Astrasono A3Pro Bladder Scanner (A3Pro) (2025), 0 descendants of its own
- K230986: Bladder Scanner (2023), 0 descendants of its own
- K223448: Bladder Scanner Model: BVT02 (2023), 0 descendants of its own

## Indications for use
The PadScan HD series Bladder Scanner is B-mode pulsed-echo ultrasound device. It is intended as a portable battery-operated device. The PadScan HD series Bladder Scanner projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. The PadScan HD series Bladder Scanner is intended to be used only by qualified medical professionals.

Source page: https://510kreport.com/device/K131227
Methodology: https://510kreport.com/methodology