# K250331: Astrasono A3Pro Bladder Scanner (A3Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Astrasono Technology Co., Ltd.
- Decided: Sep 30, 2025 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: 9 generations back to K915436 (1992). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201316: Bladder Scanner (Model: M3, M3-HD, M4, M4-HD), Suzhou Peaksonic Medical Technology Co., Ltd. (2021) Summary page 6.

## Indications for use
The "Astrasono A3Pro Bladder Scanner" is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals. Environments of intended use : Professional medical environments The intended patient population: Adult patients who require bladder volume measurement (not applicable to pediatric patients).

Source page: https://510kreport.com/device/K250331
Methodology: https://510kreport.com/methodology